Medical Devices Recall Listings: 2009

MEDICAL DEVICES RECALL LISTINGS: 2009
Hazard Classification Type II
Trade Name
Manufacturer
Recall Posting Date
Recall Start Date
Recall Number
Model or Catalog #
Lot or Serial #
Reason for Recall
A) Innova 2100 IQ Digital Imaging System B) Innova 4100 IQ System Colleague Volumetric Infusion Pump Light Wand Orotracheal Lighted Stylet ReSolve Open Back Halo Ring Process System Manager Magellan Platelet Separator Disposables
GE Healthcare
2009-01-05
2008-01-03 39234
Baxter Healthcare Corporation Vital Signs Inc. Ossur HF Roche Diagnostics Ltd. Medtronic Inc.
2009-01-05 2009-01-05 2009-01-05 2009-01-05 2009-01-05
2008-03-13 41402 2008-08-11 43632 2008-11-12 45100 2008-12-12 45358 2008-08-19 45455
Type II Type II Type II Type I Type II
Reservoirs
Maquet Cardiopulmonary AG
2009-01-05
2008-11-18 45565
Type II
Cell-Dyn Sapphire Analyzer
Abbott Laboratories Diagnostic Division
2009-01-05
2008-12-12 45612
Type III
A) Philips Multidiagnost Eleva - Image Intensifier B) Philips Multidiagnost Eleva - Flat Detector C) Omnidiagnost Eleva A) Origin YZ Zirconia Blocks B) Origin YZ Zirconia Discs Precision Charger 1.0
Philips Medical Systems Nederland B.V.
2009-01-05
2008-11-26 45311
Type II
White Peaks Dental Systems Boston Scientific Neuromodulation Corporation
2009-01-05 2009-01-05
2008-11-26 44705 2008-09-26 45208
Type II Type II
Dri-Lok Disposable Cannulas
Stryker Endoscopy
2009-01-05
2008-12-11 45616
Type II
HM Reaction Vessels
Siemens Healthcare Diagnostics Inc.
2009-01-05
2008-11-25 45624
Type III
Tenderflow Pediatric Arterial Cannula Vertier Surgical Table A) Simview 3000 B) Simview NT Therapy Simulator A) Ergolift B) Ergolift-2 Servo 300/300A A) Roche Hitachi - HDL Cholesterol B) Hitachi HDL-C Plus, 3rd Generation C) Cobas C/Integra HDL-C Gen. 3 D) Cobas C 111 HDL-Cholesterol Plus
Terumo Cardiovascular Systems Corp. Stryker Communications Siemens Medical Solutions USA, Inc. Oncology Care Systems BHM Medical Inc.
2009-01-05 2009-01-05 2009-01-05
2008-11-11 44891 2008-12-08 45617 2008-12-11 45619
Type II Type II Type II
2009-01-05
2008-12-08 45626
Type I
During acquisition (fluoro &/or record), an image could become frozen on DL (digital leader acquisition system) live monitor screen, leading the user to believe it was a live dynamic image instead. 2M8151K Product fitted with incorrect power cord (220v versus 120v) and not labelled as certified to the Canadian electrical requirement CAN/CSA C22.2 no.601.1. 3910, 3960, INTPKF >10 Numbers, Contact Mfr. There is a possibility that the light bulb protector (clear plastic bulb cover) on the end of the stylet may detach from the stylet. 505400D 8040201 The 5/16-24 class 3B threads in the Open Back Halo Rings were tapped with the wrong size or worn taps and do not pass the "go" thread plug gage. 3009696001 VERSION 2.00.02a to 2.01.05a/b Potential for a result to be released to the host (LIS/laboratory information system) before a post analytical rule (namely car rule) is triggered to block the result. BOS370, COS330, MDK300, MDK305 >10 Numbers, Contact Mfr. Becton Dickinson, a supplier of syringes, notified Medtronic that unit package seal integrity (hence sterility) can be adversely affected when exposed to low atmospheric pressure. Syringes are included in kits. BEQ-VHK 2001 276339, Heparin Lot PH64507 Celsus heparin was used during the coating process, manufactured from material that was found to contain the contaminant over-sulfate chondroitin sulfate (OSCS), which mimics heparin's anticoagulant activity. 8H00-01 Cell-Dyn Sappire Hemoglobin Reagent Syringes Cell-Dyn Sapphire 5.0ml hemoglobin reagent syringes were manufactured with a 2.5ml (08H49-02) Labelled With Packaged Dates Of syringe pull instead of the correct 5.0ml syringe pull. 16 Sept 2008. A) 70832 A) N/A A partial grid-switch failure may occur that may result in a higher x-ray dose than expected. B) 70834 B) N/A C) 708027 C) N/A A) N/A A) >10 Numbers, Contact Mfr. The product does not have a Health Canada device licence as per section 26 of the MDR. B) N/A B) >10 Numbers, Contact Mfr. As a result, a recall was issued. N/A >10 Numbers, Contact Mfr. The recall is issued due to reports of burns while using the device. The burns occurred in the area of charging, typically at the abdominal, upper buttock, and less frequently in the subclavicular area. The cannulas leak water when inserted and continue to leak when removed. There has been 3910-075-500, 3910-075-501, 3910-075- 08 135 AG2 - 08 294 AG2 a change in material without Stryker's approval. The new material has different properties 502, 3910-075-650, 3910-075-651, 3910allowing the cannulas to leak. 075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090502, 3910-090-650, 3910-090-652, 3910090-800, 3910-090-802 RXV1A NC16-182-08, NC16-210-08, NC16-238-08, Siemens Healthcare Diagnostics received customer complaints regarding reaction vessels NC16-189-08, NC16-217-08, NC16-245-08, which are leaking while running HM methods. NC16-196-08, NC16-224-08, NC16-203-08, NC16-231-08 Difficulty retracting the introducer of Tenderflow Pediatric Arterial Cannula. 813570, 813572 0502200 0513069 0507121 0512918 0788-100-001S 080118-43529 The Vertier Table was manufactured with bronze bushings at the tilt shaft instead of the validated teflon coated bushings. The bronze bushings may fail due to fatigue. A) 1957153 A) 4034, 4011 The company has become aware of a potential for serious patient injury due to excessive B) 5496992 B) 6037, 6038 wear that may occur to the drive belts used in the image intensifier and/or x-ray head drive mechanisms. A) N/A A) ERLI 0001 To ERLI 1717 BHM received incident reports describing a failure of the structure of the boom. The B) N/A B) ERLI 0001 To ERLI 1717 weakening of the welded joint due to excessive grinding may have caused the fatigue failure. 6079300, 6079391, 6079433, 6150614, 6424704, 6424712, 6424779 A) 04713257190 B) 04713109190, 04713184190, 04713214190, 04713265190 C) 04399803190 D) 04657560190 A) 360-2D, 480-2D, 720-2D B) RM-9103-S, RM-9103-S0, RM-9103S1 69318 APC-20I 667 >10 Numbers, Contact Mfr. Short inspiratory times when using Servo Ventilator 300 automode in neonatal and pediatric patient ranges. A) 697427-01 Some HDLC3 reagent lots may generate a decrease in control recovery and an invalid B) 695354-01, 697430-01, 696347-01, 697431- calibration due to calibration factor drift. 01, 697411-01, 696342-01, 697408-01 C) 695358-01, 696351-01, 601823-01, 694563-01 D) 694566-01 A) All Lots B) All Lots All Lots APC20i-0006 100413, 100805, 100974, 101114, 101511, 101677, 101714, 101769, 101854, 101989, 101576 The importer was selling research use only devices for clinical purposes.
A) 2335129-4 B) 2335129-3
A) S/N 515959BU5, 518373BU6, 534731BU5, 476532BU7, 482422BU3 B) S/N 491354BU7 & 508964BU4 >10 Numbers, Contact Mfr.
Maquet Critical Care AB Roche Diagnostics GMBH
2009-01-05 2009-01-05
2008-12-17 45668 2008-12-04 44645
Type II Type III
A) Autostainer B) Rabbit Monoclonal Antibody Clone SP3 Conform XT- Gloves Autologous Platelet Concentrate System STA-Neoplastine CI Plus 10
Labvision Corporation - Part Of Thermo Fisher Scientific
2009-01-05
2008-07-16 44328
Type III
Ansell Healthcare Products LLC Harvest Technologies Corp. Diagnostica Stago SAS
2009-01-05 2009-01-05 2009-01-05
2008-11-20 45563 2008-10-24 45706 2008-10-23 44571
Unlicensed class II medical devices. Lot APC20i-0006 failed the quarterly dose audit for sterility. A potential lack of homogeneity between product vials attributed to a defective excipient in the affected lots of products. This can impact the clotting time performance with the outcome being longer.
Hamilton Star Archive Plate
Hamilton Medical AG
2009-01-05
2008-06-01 45089
Type III
04639634001, 235656
2732709, 2742732, 2742744, 2714721, 2810259, 2811269 HL14301
The barcode label on the Star Archive Plates used with the Cobas S201 system may not be readable by either the Hamilton Star onboard barcode scanner or a hand held scanner. Complaint received from a customer indicating that the product was received with an incorrect directions for use in the package sleeve (packaged with directions for use for antia1 lectin). Debris could build up inside of the instrument to the point that it is unusable if it becomes heavily soiled. The instrument is designed to remain outside the body and should not become heavily soiled. An increased trend in reports of keypad issues occurring during implementation or shortly after being placed in use. Short circuits in the keypad may make pump inoperable or pump may not respond to keystrokes. The QP2508 hand pendant has experienced a run on condition. The linear actuator motor continues to run until end of its stroke after releasing the push button on hand pendant and then stops. Biophen Heparin 6 lots contain a substrate reagent (R1) that is harder to dissolve than usually. Sorin Group Italia received reports of restricted or blocked flow at the outlet of the minibypass bag adopted into perfusion tubing sets designed for mini-bypass systems for the models and lots specified. Difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. It was determined that the difficulty is related to specific manufactured lots. Discovered a short in the foot switch connector. It is possible that delivery of RF energy can begin without depressing the foot switch. Some lots of 12mm thick and 14mm thick provisional devices may have become commingled during manufacturing. Some units which are 12mm thick may be etched and packaged as 14mm thick provisionals and vice versa. Some of the packaging trays were cracked. This may compromise the sterility barrier. If used, the potential affect to the patient may be infection. The sheath's radiographic tip marker band may become dislodged or detached from the sheath during an interventional procedure posing an embolic risk to the patient.
Anti-H Lectin
Dominion Biologicals Ltd.
2009-01-05
2008-09-30 45736
Type III
0141-0015
Intertan Entry Portal Handle
Smith & Nephew, Inc.
2009-01-19
2008-12-15 45713
Type II
7167-4092
> 10 Numbers, Contact Mfr.
Medfusion Syringe Pump
Smith's Medical MD Inc.
2009-01-19
2008-12-29 45802
Type II
3500-306, 3500-415
>100 Numbers, Contact Mfr.
QP2508 Hand Pendant
M.C. Healthcare Products Inc.
2009-01-19
2008-12-05 45786
Type II
HB43-U010-00/01
N/A
Biophen Heparin 6 ref 221006 ECC.O Integrated Mini-Bypass System
Hyphen Biomed Sorin Group Italia S.R.L.
2009-01-19 2009-01-19
2008-11-25 45340 2008-12-31 45809
Type III Type II
221006 084221, 085339
80401, 81701, 83306 > 10 Numbers, Contact Mfr.
Trupath Biopsy Device
Boston Scientific Corporation
2009-01-19
2008-10-22 44611
Type III
N/A
Maestro 3000 Cardiac Ablation Foot SWT Nexgen Complete Knee Solution, Articula
Boston Scientific Corporation Zimmer Inc.
2009-01-19 2009-01-19
2008-11-26 45615 2008-12-19 45916
Type II Type II
M004218400 00-5971-050-12, 00-5971-050-14
> 100 Numbers, Contact Mfr. 60969810, 60969811, 61007188, 60987590, 60969807, 60976981, 60976982 M00560070, M00560071, M00560100, M00560101, M00560220 > 50 Numbers, Contact Mfr.
Gold Probe Electrohemostatic Catheter Soft Tip Introducing Sheath
Boston Scientific Corporation Boston Scientific Microvasive
2009-01-19 2009-01-19
2008-12-31 45864 2008-12-31 45865
Type II Type II
6007, 6010, 6012 5660, 5661, 5661ST, 5662, 5662ST, 5663, 5663ST, 5665, 5665ST, 5667ST, 5670, 5670ST, 5671, 5672ST, 5675ST, 5676, 5676ST, 5890ST 7.5.51 SP2, H72
Ximatron Digital Imaging 7.5.51 SP2 Updated recall # 41318 previously posted on 200803-31. Easydiagnost Eleva
Varian Medical Systems, Inc.
2009-01-19
2007-06-25 41318
Type I
H720702
Philips Medical Systems DMC GMBH
2009-02-02
2009-01-12 45982
Type II
9890 010 03631
N/A
Modular Femoral Neck BiPAP Focus Ventilator Power Cord
Encore Medical, L.P. Respironics California, Inc.
2009-02-02 2009-02-02
2008-05-27 44847 2008-09-24 45154
Type II Type II
N/A 1033869
53872833 Manufactured bef.Mar.27/ 08
A) Advia Centaur System-HIV Enhanced Assay B) Advia Centaur XP System-HIV Enhanced Assay
2009-02-02
2009-01-08 45980
Type III
A) 01463908 B) 01463908
Staphaurex Plus 150/450 BD Integra 1mlTB Syringe Ransel Kit
Remel Europe Ltd. Becton Dickinson And Company Randox Laboratories Ltd.
2009-02-02 2009-02-02 2009-02-02
2008-12-03 45985 2008-12-01 45355 2008-12-22 45734
Type II Type III Type III
RE30950102, RE30950201 305298 HG1539, RS504, RS505
Simulfluor Flu A/B Immunofluor Assay
Millipore Corporation Bioscience Division
2009-02-02
2008-11-21 45681
Type II
3121, 5250
Gendex GXCB-500 Cone Beam 3-D Imaging
Imaging Sciences International, Inc.
2009-02-02
2009-01-08 45997
Type II
G1-15-1-0
Urovysion Bladder DNA Probe Kit Terumo Advanced Perfusion System 1 Bioplex 2200 Detector Calibration Packs
Abbott Molecular Inc. Terumo Cardiovascular Systems Corp. Bio-Rad Laboratories Diagnostics Group
2009-02-02 2009-02-02 2009-02-02
2009-01-04 45862 2009-01-23 46050 2008-12-01 45218
Type III Type II Type II
36-161070 801763 660-0000
Potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as staphylococcus aureus. 8078251 There was a typo error on the label of the 100 unit shelf carton. The expiry date on this label reads 2013-13 when it should read 2013-03 (designating March 2013). 138702, 122999, 100558, 084225, 098485, Instructions for preparation of the HG 1539 reagent, required if using human blood samples 083256, 101130 for application to Ransel Kit, RS 504/ RS 505, are incorrect. The current dilution of 1 + 24 is incorrect, it should be 1 + 4. >10 numbers, Contact Mfr. Millipore confirmed that specific lots of SimulFluor Flu A/B reagent may cross react with respiratory syncytial virus, potentially leading to a misdiagnosis of influenza B, thus a recall was issued. NU010286 The phantom used for calibration of the Gendex GXCB-500 Cone Beam 3-D imaging machine is incorrect and can result in providing inaccurate measurements within the software program. N/A The device is registered as a class II, however it has been shipped with an intended use claim that was not approved and which causes the device to be considered a class III. 0013, 0017, 0020, 0021, 0144, 0193, 0396, 0601 The screws in the power MGR board may come loose and come into contact with system 1 chassis, causing a short circuit between the board and the chassis. 950413 Detector calibration packs from lot number 950413 may calibrate the Bioplex 2200 detector module incorrectly leading to the possibility of low count errors for patient samples, assay calibrators, QC material.
A) 16384031, 19633033, 28655040, 27767040, 19004033, 30279040, 28082040, 27281040 B) 19633033, 28655040, 16384031, 19004033, 30279040, 28082040, 20234033 J311610, J311510
A software code malfunction has been identified in Ximavision / Ximatron digital imaging v7.5.51.6 sp2. This only affects systems using the Ximatron simulator. Other simulators (eg. Acuity) are not affected. Patient images can be mixed up during viewing and printing. Images of one patient might be stored in the folder of another patient. This can be full images but also part images of two patients on one image. During routine in-house testing a visual discrepancy was found. The visual nonconformance consisted of a scallop feature with twice as many lobes, 24 instead of 12. This corrective action is being taken to address power supply failures on some ventilators. The failures are a result of transient power surges created from disconnection or intermittent electrical connection. Investigation showed some reagent lots exhibited a loss in type O sensitivity which could potentially result in a missed detection of a HIV type O infection specifically during seroconversion.
A) Liquicheck Cardiac Markers Control LT - Trilevel B) Liquicheck Cardiac Markers Control LT - Level 1 C) Liquicheck Cardiac Markers Control LT - Level 2 D) Liquicheck Cardiac Markers Control LT - Level 3 E) Liquicheck Cardiac Markers Control LT - Trilevel Minipak Carina Home Ventilator Minute Lab PSA Semi-Quantitative Test A) Achieva 3.0T MRI System-Main Unit B) Achieva 1.5T MRI System-Main Unit C) Achieva XR MRI System-Main Unit D) Intera 1.5T MRI System E) Intera 3.0T MRI System-Main Unit A) Voluson E8 Ultrasound System B) Voluson E8 Expert Ultrasound System Giraffe Omnibed Rear Case Assembly For Auto Syringe
Bio-Rad Laboratories
2009-02-02
2008-11-28 45219
Type II
A) 145 B) 146 C) 147 D) 148 E) 145X 5703700 PSD-A1, PSS-A1 A) Achieva 3.0T B) Achieva 1.5T C) Achieva XR D) Intera 1.5T E) Intera 3.0T A) N/A B) N/A
A) 23430, 23440 B) 23431, 23441 C) 23432, 23442 D) 23433, 23443 E) 23430, 23440 Version 1.1-2.4 PSA 6090007, PSA 6090008 A) N/A B) N/A C) N/A D) N/A E) N/A A) >10 numbers, Contact Mfr. B) D03347, D03345, D03655
NT-proBNP and Troponine I do not meet the 20 day open vial claim. Package insert have been revised to indicate that NT-proBNP will be stable for 10 days and Troponine I will be stable for 8 days at 2-8 c.
Draeger Medical B.V. Tremblay Harrison Inc. Philips Medical Systems Nederland B.V.
2009-02-02 2009-02-02 2009-02-02
2009-01-14 46109 2008-09-19 46147 2008-09-26 44066
No device alarm when pilot line gets disconnected. Current product is unable to meet performance requirements which may yield false negative prostate specific antigen results at or near the limit of detection. Lithium polymer battery for the VCG sensor may fail after being physically dropped from a height (i.e.1 metre). The failed battery may produce a flame or emit smoke. The failure may occur instantly or delayed.
GE Medical Systems Kretztechnik GMBH & CO OHG
2009-02-02
2008-04-01 42409
Type III
Ohmeda Medical, A Division Of Datex Ohmeda Inc. Baxter Healthcare Corporation
2009-02-02 2009-02-02
2008-07-31 43008 2008-09-19 43803
Type II Type II
Durepair Dura Regeneration Matrix
Medtronic Inc.
2009-02-02
2008-11-17 45672
Type II
Galileo Echo Blood Bank Analyzer
Immucor Inc.
2009-02-02
2008-11-21 45821
Type II
Prosolv Cardiovascular Image and Information Management A) Innova 2100/2100 IQ Digital Monitoring B) Innova 4100 IQ
Problem Solving Concepts, Inc. GE Healthcare
2009-02-02 2009-02-16
2008-10-24 46106 2008-06-18 42702
Type II Type II
A) Evita 4 B) Evita 2 Dura C) Evita XL A) Securefit Hip Stem - 132 degree B) Securefit Hip Stem - 127 degree C) Solar Shoulder - Humeral Component D) Osteonics Omnifit Hip Stem Access Immunoassay Systems Inhibin A Innova 2121 IQ Vibe Machine
Draeger Medical AG & CO. KG
2009-02-16
2008-06-23 42978
Type II
Howmedica Osteonics Corporation
2009-02-16
2008-09-22 44184
Type II
When focal zoom is activated and M-mode is on, performance measurements on M-mode trace may not be accurate. When sonographer unfreezes the image and freezes again, measurements may or may not be accurate. Omnibed >10 numbers, Contact Mfr. There is an accumulation of debris and discolouration on component assemblies of the device, emphasizing the canopy seal area. 1M8560R AAS5001530RP, AAS5001531RP The ESD grounding squares were incorrectly placed on an AS50 rear case assembly. The conductive copper side instead of the kapton side was incorrectly facing the I/O printed circuit board assembly. 61100, 61103, 61105, 61106, 61107, All Lots Preliminary data suggests that the foreign body reaction of concomitant use of some 61110, 61111, 61113, 61151, 61152, ancillary products with Durepair is more pronounced than Durepair alone and may increase 62105, 62110 rates of other known risks. N/A M00265 With the implementation of version 1.1.2.28, Immucor discovered when a clot was detected, the probe moved to the rinse station before the operator responded to the user prompt whether the probe was clean. PROSOLV CARDIOVASCULAR CL , VERSIONS 3.5.1776, 3.5.1530, 4.0.1.142, A software defect was detected with its cardiology pacs software when exporting a patient's PROSOLV CARDIOVASCULAR SE 3.5.43, 3.0.48 diagnostic images to a CD. A) S18751AM, S18751AP A) S/N's 1203100025, 452849BU3, 112436VE1, The LCD monitor support may disengage from its arm and fall on the table. Incorrect cable B) S18391MD 452927BU7, 524113BU8 routing may cause the ECG monitor power cable to be damaged, potential for short circuit, B) S/N's 1203/00034, 1203/00030, 604/20097, sparks & electric shock. 460566BU3, 112438VE7, 469393BU3 A) 8306611, 8412980 A) ARXM-0005 The power failure alarm generator sporadically emits signal at a high, barely perceptible, B) 8306611, 8411800 B) ARYB-0067 frequency. Affects only units in which the replacement CO2 carrier PCB installed between C) 8306611, 84119600-XX C) ARYB-0044X 2005 and 2008 during a repair. A) 6051-0830S, 6051-0935S, 6051-1140S A) 901MME, EN1MME, J41MLE, 4PMMME Voids of various size were found in the seal area of a series of blisters processed on a B) 6054-0812S, 6054-1014S B) AKKMME, 72MMME specific heat sealer. They are related to a progressive scratch on the heat plate that caused C) 5351-4108 C) VV4MKE the voids in some packaging. D) 6070-0730A, 6070-0830A D) VK0MME, D9VMME, RHWMME A36097 S18821AM N/A N/A S/N 554413BU5 N/A The Inhibin A certificate of analysis has the incorrect unit of measure listed as iu/ml. The correct unit of measure is pg/ml. 1) Intermittent failure associated with the function used to store images. 2) Software failure on the function used to send images for storage on the hard disk. Company did not obtain marketing approval before offering vibe machine for sale...product is a device because it is intended for use in diagnosis of disease or in cure, treatment, or prevention of disease. In certain circumstances, a patient number could be erased and replaced with the patient's hospitalization number. This defect could lead to a patient identification mismatch. Specified lots of sprayed HA stems produced did not meet Stryker's internal material specification for tensile bond strength and crystallinity.
Beckman Coulter Inc. GE Healthcare Vibe Technologies
2009-02-16 2009-02-16 2009-02-16
2008-10-15 44413 2008-11-18 45109 2008-12-26 45192
Type III Type III Type III
TD-Synergy Software (TD-SYN-01)
Technidata S.A.S.
2009-02-16
2008-12-11 45827
Type II
N/A
N/A
A) Osteonics Omnifit M-HA Hip Stem B) Accolade TMZF Press Fit Stem 132 Degree C) Accolade TMZF Press Fit Stem 127 Degree
Howmedica Osteonics - Stryker Ireland
2009-02-16
2009-01-06 45981
Type II
A) > 10 Numbers, Contact Mfr. A) 6041-0730, 6041-0830, 6041-0935, B) > 10 Numbers, Contact Mfr. 6041-1035, 6041-1140 C) > 10 Numbers, Contact Mfr. B) 6020-0130, 6020-0230, 6020-0335, 6020-0435, 6020-0537, 6020-0637, 60202530, 6020-3535, 6020-4535, 6020-5537 C) 6021-0130, 6021-0230, 6021-0335, 6021-0435, 6021-0537, 6021-2530, 60213535, 6021-4535, 6021-5537 A) GTI-72C, GTI-72L, GTI-72OR B) GTI-B27 C) GTI-DR A) 32.5, 32.6, 32.7, 10.3, 10.7 B) 16.2 C) 55.0
A) HLA Typing Trays B) HLA Typing Trays - B-27 C) HLA Typing Trays - Class II
GTI, Inc.
2009-02-16
2009-01-12 46071
Type III
Reactivity of HLA Typing Trays has changed since the products were released. At the time of release, product met the specifications for reactivity, but upon storage and shipment, reactivity has declined.
A) Axiom Artis DBA B) Axiom Artis DTA C) Axiom Artis DMP D) Axiom Artis DBC E) Artis Zee Multi-Purpose F) Artis Zee Ceiling G) Artis Zee Biplane H) Axiom Artis FC I) Axiom Artis DFC J) Axiom Artis DFC K) Axiom Artis FA L) Axiom Artis MP M) Axiom Artis BC N) Axiom Artis BA O) Axiom Artis TA
Siemens AG
2009-02-16
2008-08-06 43374
Type II
A) 7555357 B) 7008605 C) 7555365 D) 59 17 054 E) 10094139 F) 10094137 G) 10094141, 7728392 H) 59 04 433 I) 7727717 J) 7412807 K) 5904441 L) 5904466 M) 5904649 N) 5904656 O) 7007755
A) AMX 4 Mobile X-ray System B) AMX-4+ Mobile X-ray System 2.0mm Stainless Steel Crimp Sleeve A) Sterile ECLS Pack B) Sterile Lap Chole Pack C) Sterile Lap Chole Pack D) Ens. Strl. Pour Sternotomie E) Sterile Major Laparoscopic Pack F) Ens. Pour Endocholecystectomie G) Ens. Pontage Femora-Poplite H) Sterile Emergency Chest Pack I) Sterile Aneurysm Pack J) Strl. Radical Prostatectomy Pack K) Sterile Nephrectomy Pack L) Sterile Craniotomy Pack M) Sterile Mastectomy Vic Pack N) Oto-Rhino-Laringologie Mineure O) Strl. Ambulatory Minor Vacular Pack P) Sterile AAA Victoria Pack Q) Ens. Pontageaorto Bifemoral R) Ens. Strl Chirurgie De L'Aorte S) Sterile AV Fistula Pack T) Sterile Major Abdominal Pack
GE Healthcare
2009-02-16
2008-10-03 44190
Type II
A) 2115090, 46-270157G-1 B) 2275938-7 350805 A) SCV30CBXXX B) SLC30LCXXX C) SCV30AAXXX D) SCV30STXXX, SCV30THXXX E) SBA30MLXXX F) SBA30ENXXX G) SCV30FPXXA, SCV30FPXXX H) SBA30THXXX I) SBA30THXXX J) SOT30RPXXX K) SBA30NPXXX L) SNE30CNXXX, SNE30CRXXX M) SBA30MYXXX N) SBA30ELXXX, SBA30LBXXX, SBA30MNXXX, SBA30OL'XXX', SLC30LAXXX, SLC30LCXXX, SLC30LPXXX O) SBA30MVRHA P) SBA30AAXXX, SCV30AOXXX Q) SCV30ABXXX, SCV30ACXXX R) SCV30CEXXX, SCV30CVXXX, SCV30EAXXX S) SCV30AF'XXX' T) SBA30MAXXX
Biomet Orthopedics, Inc. Cardinal Health
2009-02-16 2009-02-16
2008-09-24 44279 2008-09-22 44332
Type II Type II
A) 53069, 53081, 53088, 53097, 53101 B) 55127, 55140, 55142, 55143, 55144, 55145, 55168, 55197, 55203, 55209, 55236, 55257, 55303, 55402, 55433, 55080, 55437, 55092, 55119, 55122 C) 57017, 57026, 57030, 57047, 57052, 57064, 57068, 57119, 57123, 57160 D) 49003 E) 157105 F) 146106 G) 153146, 153163, 44212, 44217, 44274, 44102, H) 10037, 10311, 10376 I) 40033 J) 35051, 35177, 35749, 35195, 35216, 35219, 35298, 35391, 35417, 35531 K) 25006, 25055, 25076, 25147 L) 20002, 20018, 20039, 20069, 20070, 20151, 20163, 20215 M) 14026, 14041, 14054, 14080 N) 28016, 28022, 28048, 28064, 28069, 28072 O) 32070 A) S/N'S 280105WK8, 311216WK6, 263322WK0, 219252WK4, 467148WK3 B) S/N 966367WK5 S/N 568400 A) 813434, 820299, 827471, 829163, 858988 B) > 10 Numbers, Contact Mfr. C) > 10 Numbers, Contact Mfr. D) 826939, 835300, 838978, 844676, 853786, 817677, 824596, 834460, 841029, 846104, 851508, 855864 E) 819184, 826942, 839638, 844698, 847088, 851615 F) > 10 Numbers, Contact Mfr. G) > 10 Numbers, Contact Mfr. H) > 10 Numbers, Contact Mfr. I) 757212, 773368, 788682, 791871, 793268, 826324, 831416, 843528, 847389, 852782 J) > 10 Numbers, Contact Mfr. K) 746846, 758604, 776580, 796554, 805480, 814976, 845580, 852840 L) > 10 Numbers, Contact Mfr. M) 857254 N) > 10 Numbers, Contact Mfr. O) > 10 Numbers, Contact Mfr. P) > 10 Numbers, Contact Mfr. Q) > 10 Numbers, Contact Mfr. R) > 10 Numbers, Contact Mfr. S) 757636, 764645, 784768, 797005, 809371, 824689, 834298, 842836, 848983, 855432 T) 753435, 765517, 787942 A) S/N E9-0148 B) S/N 7019-CMH > 100 Numbers, Contact Mfr.
A customer safety advisory notice was issued to notify customers about important instructions regarding patient safety on the Artis system.
Battery sensor board was not insulated. Metal objects could fall on the board during servicing of the systems that may result in sparks. Outer box labelled as a 2.0mm crimp sleeve may contain an alternate label on the inner packaging.
Customs kits manufactured by Source Medical contain titanium clips being recalled by Teleflex Medical.
A) OEC Mobile Elite C-Arms Gen. Platform B) OEC Mobile Elite C-Arms Cooling Wizard Low Profile Gastrostomy Device
GE OEC Medical Systems Inc.
2009-02-16
2008-09-25 44335
Type II
A) S2024DT B) S2024EH 00200W, 00201W, 00202W, 00203W, 00204W, 00205W, 00206W, 00207W, 00210W, 00212W, 00213W, 00214W, 00215W, 00216W, 00217W, 00218W, 00221W, 00222W, 00223W, 00224W, 00225W A) 04385983, 129501 B) 04385983, 129501 2M86955
Bard Access Systems, Inc.
2009-02-16
2008-10-09 44381
Type II
The device may not conform to Federal regulations for proper beam alignment and overlap requirements in the mag 1 or mag 2 X-ray mode for systems manufactured on or after June 10, 2006. Leaflet fractures, which could cause leakage from the device of gastric contents and feeding solutions.
A) Advia Centaur XP B) Advia Centaur Oxylog 3000 Ventilator
Siemens Healthcare Diagnostics Inc. Draeger Medical B.V.
2009-02-16 2009-02-16
2008-10-14 44404 2008-10-22 44596
Type III Type II
A) 138 B) 138 SRYB-0074, SRYB-0132
Diamond Mammography X-ray Equipment
GE Healthcare
2009-02-16
2008-10-09 44731
Type II
81000
S/N'S 20572 & 20693
Centricity QS Perinatal System
GE Healthcare Integrated IT Solutions
2009-02-16
2008-10-02 45092
Type II
2033579-008
S/N'S J4RR1420F, L4RR1515F
A low bias between serum and the plasma samples is greater on reagent lot 138 when compared to other lots. Ventilating in bipap mode with the pressure rise time set to the highest setting and the expiration time being exactly 0.5 seconds which will lead to inspiration phase stopping and ventilation will resume in 5 seconds. Screws holding the rails on the easy compression system (ECS) assembly were not appropriately tightened and could create a potential hazardous situation if the C-arms were to fall. The in, out & net fluid totals values will not honour the numeric precision configuration, which will display a whole number, losing decimal point accuracy for low weight patients such as infants.
A) Gemini GXL 6/10/16 Slice PET/CT System B) Gemini TF 16 PET/CT System C) Gemini TF 64 PET/CT System A) Advantage Workstation Version 4.2 B) AW Volumeshare C) AW Volumeshare 2
Philips Medical Systems (Cleveland), Inc.
2009-02-16
2009-01-16 46137
Type II
GE Healthcare
2009-02-16
2008-04-04 42738
Type II
Floseal Endoscopic Applicator Aisys Anesthesia Carestation
Baxter Healthcare Corporation Datex-Ohmeda, Inc.
2009-02-16 2009-02-16
2008-08-06 43320 2008-10-15 43371
Type II Type III
A) 4535 673 04201 B) 4535 673 89331 C) 4550 110 09021 A) 2378698-2, B77001ST, B78001ME, B79991EP, B79991SS B) B79991SS C) 2378698-2, 5142883, 5173500, 5174073, 5183998, B77121VB, B79831SR, H25801BP, P51801BP 1500181 1011-8302-000
A) N/A B) N/A C) N/A A) > 10 Numbers, Contact Mfr. B) 62426G, 62427G, 14513A, 59993G, 69491G, 63624G C) > 10 Numbers, Contact Mfr.
The transducer used for pulmonary gating kit of the CT subsystem relays inaccurate signals in the bellows system. This could result in an image being displayed with an incorrect phase of the respiratory cycle. AW version 4.2, AW Volumeshare (4.3) & AW Volumeshare 2(4.4): the software incorrectly reloads a save state/save tracking & display incorrect vessel name over restored images. Mismatch of vessel labels.
07E025, 07F012, 08A027 > 10 Numbers, Contact Mfr.
Duralite Pyramid Receiver Proximal Adaptor A) Easy Core Biopsy System B) Easy Core Biopsy Needle - Delta Notch
The Ohio Willow Wood Company Boston Scientific Corporation
2009-02-16 2009-02-16
2008-09-11 44165 2008-10-24 44614
Type II Type III
FND-136102 A) M001434561, M001434571, M001434581, M001434591, M001434601 B) M001434501, M001434511, M001434521, M001434531, M001434541
Synfix LR, Low Profile U-Joint Driver Artiste MV
Synthes (Canada) Ltd. Siemens Medical Solutions USA, Inc. Oncology Care Systems
2009-02-16 2009-02-16
2009-01-19 46154 2009-01-22 46187
Type II Type II
03.802.231 8139789
N/A A) 11524979, 11546134, 11516921, 11550539, 11518343, 11535832, 11634771, 11520769 B) 11524375, 11535831, 11532167, 11554902, 11516922, 11532173, 11547760, 11569929, 11520532, 11539484, 11579252, 11642796, 11520676, 11551300 N/A S/N 5414
There was a presence of a dark discolouration of the Floseal material as it was pushed through the sleeve. The back pressure and inflow check valves may leak. The cassette interface board fails to establish communications with other devices and losing the electronic agent level indicator with no alarms given. In-house long term testing has indicated the adapter may crack in extreme situations. Difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. Investigation shows that is related to specific manufactured lots.
Miltex Stainless Steel Surgical Blades 3160 MRI Sytem-Power Battery Components
Miltex, Inc. Invivo Corporation
2009-02-16 2009-02-16
2008-11-17 46242 2008-08-13 46281
Type II Type II
4-312B 9065
S07C06 Date Codes 2808 And Lower
Signa 3.0T Excite HD - Magnet
GE Healthcare
2009-02-16
2008-04-04 41528
Type II
N/A
N/A
Ponsky Non-Balloon Gastrostomy Tube A) Capture-CMV Indicator Red Cells B) Capture-S Indicator Red Cells Fuji Synapse Image & Information System Unicel DXC 880I Synchron Access Clinical System Precision Spinal Cord Stimulation System A) Axis Variable-Angle Dual-Detector Gamma B) Irix Triple Detector Camera CGMS IPRO System - Solutions Software
Bard Access Systems, Inc. Immucor Inc. Fuji Film Medical Systems USA, Inc. Beckman Coulter Inc. Boston Scientific Neuromodulation Corporation Philips Medical Systems (Cleveland), Inc.
2009-02-16 2009-02-16 2009-02-16 2009-02-16 2009-02-16 2009-02-16
2008-05-16 42263 2008-12-15 45761 2008-12-18 46160 2009-01-21 46185 2008-09-26 44523 2008-10-14 46012
Type II Type III Type III Type II Type II Type II
000630, 000631 A) 0066238 B) 0006428 N/A A59102, A59126 SC-5300 A) N211037, N211039 B) N211038, N211040 MMT-7319
HURJ0589, HURJ1533, HURE3333, HURG1431, HURJ0568 A) 228083 B) 221299 N/A 0205, 0206 7392, 7455, 8015, 8731, 8768, 10686, 10949, 11625, 12198, 8733, 11460, 11724 A) N/A B) N/A N/A
Complaints received for distal tip breakage of the Synfix LR, Low Profile U-Joint Driver with instances of the tips remaining in the patients. On inserting the accessory, the IL26 accessory insertion interlock indication may disappear from the monitor even if the accessory is not locked in accessory holder preventing gantry and collimator motion. The blades appear to have an excessive taper at the tip of the blade and may break during use. The lithium polymer battery may fail after being physically dropped from a height. Failed battery may momentarily produce a flame and then emit smoke. The failure may occur instantly or after short period. When using PROPELLER T2 FLAIR application on 3T HD systems the surface coil intensity correction image enhancement option made Hippocampus brighter than images taken with the SCIC option off. Dome develops a tear during device stretch & distention with an obturator or the obturator may slip out of the pocket during placement. All vials within the product lot have been printed with the same serial number. When scrolling through the images of a series, the scrolling appears choppy, hesitates, jumps ahead and is not smooth. There is potential to have incorrect patient information associated with results on the DxI console and DxI printed reports when the DxC database is renewed. Reports of charger 1.0 burns have been reported. Burns occurred in the area of charging while using the charger 1.0. Devices may overheat (that have the active shunt module retrofit) resulting in the appearance of smoke, a burning smell, and an e-stop condition. This will disable the system rotate motion and all other motions. There is an error in Solutions Software for iPRO (model MMT-7319 version 2.1A) when the program is set to display blood glucose values in mmol/litre and they are exported for use in another program. If the retaining ring inside the column assembly is not inspected and replaced when worn or loose there is the potential for the supporting cable to become detached from the column causing the column to fall. Boston Scientific identified, through internal testing of the product a potential of a breach to the sterile barrier. Specifically, the package seal may degrade after sterilization. There is a software code error, which could result in inaccurate calculations and displays of the group peritonitis rate. When the zoom mode is used for breast imaging, there is a spatial distortion that can be seen on 3D lateral images. Ground path on the workstation mounting bracket is suspect. Single fault conditions exist that could energize the mounting bracket, resulting in a noncompliance with regulatory requirements.
Medtronic Minimed
2009-02-16
2009-01-12 46194
Type III
Ceiling Tube Mount With Column Extensions
DEL Medical Imaging Corporation
2009-02-16
2009-01-26 46273
Type II
CTM/DCTM
Contact Mfr.
Steerocath Steerable Catheter Non Temperature
Boston Scientific Microvasive
2009-02-16
2008-02-20 46322
Type III
2028BL
0011043537, 0011049772, 0011059410, 0011069509, 0011078605 Software Version 4.201 Cat.# 2850101 A) S/N#S 251168MR1, 7831GQ1, 1078GQ5 B) > 10 Numbers, Contact Mfr. A) P6-0404-R, P6-0396-L, P6-0528-R, P6-0390R, P4-0433-R, P4-0376-R, P4-0400-R B) > 10 Numbers, Contact Mfr. C) N/A D) > 10 Numbers, Contact Mfr. 97525
Patient On-Line A) 3.0T Signa HDX MR System - Main Unit B) 1.5T Signa HDX MR System - Main Unit A) Uroview 2800 System - Urological Table B) OEC Miniview 6800 Digital Mobile Unit C) OEC Flexview 8800 Standard C-Arm D) OEC 9800 Plus Mobile Digital System Modular Microplasty Cup Inserter
Fresenius AG GE Healthcare GE OEC Medical Systems Inc.
2009-02-16 2009-02-16 2009-02-16
2008-04-06 41821 2008-05-23 42811 2008-04-25 42976
N/A A) M3335JM B) M3335JB, M3335JG A) 00-870638-02 B) 00-870637-02 C) 2350023 D) 00-870632-05, 2274023 N/A
Biomet, Inc.
2009-02-16
2008-07-28 43310
Type II
The pin and clip may fracture during surgery. Affected lots were found to be non-conforming to firm's explicit specifications.
Centricity PACS Workstation Software
2009-02-16
2008-11-17 43840
Type II
A) Solar 8000I System - Patient Monitor B) Patient Data Module Datex-Ohmeda Network Aand Icentral
GE Healthcare
2009-02-16
2008-08-26 43880
Type II
> 100 Numbers, Contact Mfr. 2023617-XXX, K2004W, K2004Z, K2006WB, K2006WC, K2006WD, K2006WE, K2006WF, K2006WG, K2006WH, K2006WJ, K2022PD, K2022PE, K2022PF, K2022PG, K2022PH, K2022PJ, K2022SA, K2022SB, K2022SC, K2022SD, K2022SE, K2022SF, K2030JN, K2030MR, K2033JF, K2033L, K2033LB, K2033LC, K2033LE, K2033LG, K2033SE, K2033SF, K2070L, P0001KA, P0001KC A) SLR8KI-XXX-XXX-XXX-XXX A) N/A B) PDM-XXX-XXX-XXXX B) N/A M1113714, M1113715 > 10 Numbers, Contact Mfr.
If DDP configured to place current & historical studies in different regions than system default, user may think old study is new one. Patient jacket content may mis-match image displayed.
GE Healthcare Findland OY
2009-02-16
2008-12-17 44822
Type II
A) Immulite 2000 System-Analyzer Class III B) Immulite 2000 System-Analyzer Class II C) Immulite 2000-Instrument Class IV
2009-02-16
2009-01-22 46193
Type II
A) 030002-03 B) 030002-03 C) 030002-03
A) F0813 B) F0813 C) C0181R
Bremer Halo Mayfield Adapter
Depuy Spine
2009-02-16
2009-01-30 46344
Type III
AC003
055561, 055562
Sterrad 50 Sterilizer
Advanced Sterilization Products, A Division Of Ethicon Coloplast A/S
2009-02-16
2009-01-13 46352
Type II
10050
Philips Bougie
2009-02-16
2009-01-23 46373
Type II
AG55XX
All Manufactured Between 2003-2008
Stille Sonestra 6210 Fluoroscopy Table
Stille AB
2009-02-16
2008-08-27 44642
Type II
N/A
N/A
Oxoid Fraser Broth Base A) Variant II System with CDM 3.5 software B) Variant II Turbo with CDM 3.6T System Elekta Precise Treatment Table
Oxoid Limited Bio-Rad Laboratories Diagnostics Group
2009-02-16 2009-02-16
2008-08-18 45182 2009-02-02 46347
Type II Type I
CM0895B A) N/A B) N/A MRT 5071, MRT 5111, MRT 5121
649795, 667911, 649794, 667910, 662546 A) N/A B) N/A NEBATO 124001 TO 124515, CHINA 125001 TO 126001, Hexapod ready 133801 to 133860, Axesse NPSS 133801 to 133860 040712, 060622, 522267
Elekta Limited
2009-02-16
2009-01-23 46393
Type II
Loss of monitoring at Solar 8000i for approx. 1-2 minutes as a result of unexpected reset of Solar 8000i monitor. Problem occurred when solar 8000i, patient data module and telemetry used in combo mode. ICentral does not provide audio or visual alarms for: 1) AFIB, VT>2 & PVC(1) when used with ApexPro, 2)VT>2 & PVC(1) when used with solar, dash or eagle (cardiac package software only). An investigation revealed that the digital fluidics PC board (PN 450116-002) contains an engineering design flaw (a missing jumper) which affects samples diluted on board. / Une enqute a rvl que la carte de circuits imprims de logique fluidique (numro de pice 450116-002) comporte un dfaut de conception technique (cavalier manquant) qui concerne la dilution dchantillon par la carte lectronique. There is a missing thread feature on both components of the device (the anterior and posterior adapters) that would make the unit unusable because it will not attach to the Mayfield swivel adapter. There is a remote circumstance that could cause a capacitor in the vacuum pump component of the system to overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire. One vigilance case & 2 complaints were received in 2008 in relation to the Philips catheter, 1 eye, female metric thread. The metallic tip detached from the shaft upon or prior to using the device. A short circuit may lead to a malfunction in the control box. This can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply. Labelling error. Portuguese instructions for preparation indicate to add 12.9g of CM0895 to one litre of water. Correct amount of water should be 225ml. Bio-Rad recommends to carefully review the summary report for duplicate tube position numbers or barcode ID within the same rack. Such duplication could potentially lead to discrepant sample results. An issue has been identified that in desktop pro release 6.1, 6.2 and 7.0 sites with precise table, there is a possible error (of up to 8mm) in the reported table longitudinal position.
Unisplint, Maxillofacial Fracture Kin
Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation Ortho-Clinical Diagnostics Inc.
2009-02-16
2008-11-08 45053
Type III
01-1100
Vitros DT Calibrator Kit
2009-03-02
2009-02-03 46501
Type III
1957927
25 And Above
Logiciel TDHisto/Cyto Software A) Engstrom Carestation B) Engstrom Carestation - Trolley Options Aquarius System
Technidata S.A.S. Datex-Ohmeda, Inc. Edwards Lifesciences LLC
2009-03-02 2009-03-02 2009-03-02
2008-10-11 44729 2008-02-12 40775 2008-12-01 45544
N/A A) 1505-9000-000 B) 1505-8538-000 GEF09700
N/A A) > 10 Numbers, Contact Mfr. B) > 10 Numbers, Contact Mfr. > 10 Numbers, Contact Mfr.
Minimally Invasive Solutions Technology Offset Rasp Handles CoCr Head 0 32/+4L Taper 12/14 Aquilion One A) Coonrad-Morrey Total Elbow - Humeral B) Coonrad-Morrey Total Elbow - Ulnar Abbott Prism HBsAg
Zimmer Inc. Zimmer GMBH Toshiba Medical Systems Corporation Zimmer Inc.
2009-03-02 2009-03-02 2009-03-02 2009-03-02
2008-12-31 46270 2009-01-22 46271 2009-01-27 46272 2009-02-06 46533
Type II Type III Type II Type II
00-7806-035-01, 00-7806-035-02 14.32.07-20 TSX-301A/2
> 10 Numbers, Contact Mfr. 2405362 N/A
The outer label of the Unisplint rubber bands (part of Maxillofacial Fracture Kit) indicated natural rubber latex while the inner label indicated latex free. The inner label is the correct label. The calibrator kit storage and stability conditions require an update for lots 25 and above. The calibrator response may be lower than expected for alkaline phosphates for concentrations above 400 u/l. A user working in TDHC who launches the "work in progress" function is attributed the rights of another user. Dual fault failure mode of Engstrom system may occur that can cause patient airway pressures to exceed the user settable PMAX limit. 1) Operating manual incorrectly depicts the connection of the filtrate line & filter, for machine operation in the hemofiltration mode. 2) Deviations in the total fluid loss (TFL) balance alarm. There is potential of the C-clip located near the connection end could fracture or fall off the device and into the wound. Some units from this lot may not be etched with the item number and lot number on the rim. The surestart function may not operate normally and the exam plan may be interrupted or the scan start timing of the actual scan may be delayed as a result. Review of the current surgical technique was initiated relative to canal preparation for the extra-small humeral component. It was determined that the instruction provided could be misinterpreted. There is an increase in frequency of drain time errors (3X223, 3X224, 3X225) leading to results not being generated when testing some patient samples with lot number 68761HN00. Product labelled as 9-10mm Ezloc Femoral Fixation "standard length" actually contained "long length". There was a cross mix between two batches of Triathlon Primary Cemented Baseplates, size 2 and size 4, for the specified lots.
Abbott GMBH & Co. K.G.
2009-03-02
2009-02-06 46534
Type III
A) 32-8105-027-04, 32-8105-027-06 A) N/A B) 32-8105-043-01, 32-8105-043-02, 32- B) N/A 8105-093-01, 32-8105-093-02 3A47-48 68761HN00
9-10mm Ezloc Femoral Fixation Device Triathlon Primary Cemented Baseplate
Biomet Sports Medicine, Inc. Howmedica Osteonics Corporation
2009-03-02 2009-03-02
2008-09-18 44280 2009-01-23 46208
Type II Type II
904781 5520-B-400
164080 J5119SH8NT
Triathlon Primary Cemented Baseplate Octeia 25-Hydroxy Vitamin D Kit Vasoview 6 Endoscopic Vessel Harvesting Heartstring II Proximal Seal System
Howmedica Osteonics Corporation Immunodiagnostic Systems Ltd. Maquet Cardiovascular LLC Maquet Cardiovascular LLC
2009-03-02 2009-03-02 2009-03-02 2009-03-02
2009-01-29 46302 2009-02-02 46543 2009-02-06 46544 2009-02-09 46546
Type II Type III Type II Type I
5520-B-200 AC-57F1 VH-2000 HSK-2038, HSK-2043
SJE3F 62729
There was a cross mix between two batches of Triathlon Primary Cemented Baseplates, size 2 and size 4, for the specified lots.
During internal testing, low absorbance values were observed when using kits from this batch. Investigation has shown the cause of the low absorbance values to be the biotin buffer.
Fastrac "Pull" Gastric Access Port Kit Focal Software CD
Bard Access Systems, Inc. Computerized Medical Systems
2009-03-02 2009-03-02
2008-12-23 45860 2009-02-06 46521
Type II Type II
5729 N/A
Cytomics FC 500 Flow Cytometry System A) Sterile Pacemaker and Defibrillator Pack B) Sterile Shoulder Pack Enzymatic Creatinine Assay Amsorb Plus Prefilled Bubble-Can Universal WTOV
Beckman Coulter Inc. Cardinal Health Genzyme Diagnostics P.E.I. Inc. Armstrong Medical Limited
2009-03-02 2009-03-02 2009-03-02 2009-03-02
2009-02-11 46568 2009-02-11 46636 2009-02-12 46641 2009-02-05 46652
Type III Type II Type II Type II
626553 A) SAN30PAXXX B) SOP30ASXXX N/A N/A
Blood Tubing Set for Hemodialysis
Nipro Corporation
2009-03-02
2008-12-10 45627
Type II
A230TR/V810TR
A) PDSII (Polydioxanone) Monofilament Suture B) Coated Vicryl Absorable Suture C) PDS II (Polydioxanone) Suture D) Monocryl Plus Antibacterial Suture E) Coated Vicryl Plus Antibacterial Suture
Ethicon Inc.
2009-03-02
2009-02-02 46404
Type II
A) Z117H, Z320H, Z969H B) DC512, J286G, J544G, J546G, J547G, J699H, J834G, J945H C) Z-991G, Z305H D) MCP496G E) VCP416H, VCP534H, VCP602H, VCP615H, VCPB340H A) 4535 670 88051 B) 4550 110 02031 03-2794-0 7142-4053
8090272, 8090571, 8110571, 8100771, 8070771 During a routine shelf-life aging test, a small number of devices exhibited signs of damaged packaging, which may lead to compromised sterility. 8120271, 8101072 During a routine shelf-life aging test, a number of devices exhibited signs of damaged packaging, which may lead to compromised sterility which has 30% chance of death as the contamination is on the bloodstream. > 10 Numbers, Contact Mfr. Looped portion of the grasping snare may detach from the crimp and remain in the patient during the guidewire grasping and replacement process. Release 4.1.1 & Higher Once individual MLC leaf position edits are made, original MLC aperture is retained. Further edit will snap MLC leaves back to original aperture. Isocenter shift made in XIO will also cause same. N/A Erroneous but credible results may be generated when prism plot results are not updated consistently when exported to spreadsheet software. A) 872728, 875378 The recall has been initiated due to a failure in the sterilization and the manufacturer is B) 872013 unable to assure the sterility of these products. 31895, 32120, 32689, 32565, 32383 Five kit lots of product were incorrectly labelled with a date that extends past their 18 month expiration. 08090F12 Upward force of the inner sealing ring on the mating surface of the Drager Clic adapter is insufficient to fully open the gas circuit due to a defect in the plastics body resulting in absorbent failure. 8102 Cracking of the priming set drip chamber which is pre-attached to the arterial line was reported. Cracking and leaking of the chamber compromises the sterility of the device raising contamination issues. A) APM797, APM298, APM980 Ethicon is conducting a recall of 21 lots and 19 corresponding product codes of absorbable sutures for which sterility cannot be assured, due to a failure in the sterilization process. B) APM272, APZ116, APM400, AP6072, APM384, APM401, APM324, APM775, APZ363, AP2615 C) APZ490, APM844 D) APZ414 E) AP2599, APM984, APZ804, APM982, APZ372 A) N/A B) N/A > 10 Numbers, Contact Mfr. 06DM08612 There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved based upon their series ID. On specific lot numbers of twister combiset bloodlines a twister port may crack and separate, which may result in potential blood exposure and/or blood loss for the patient. A Legion 20mm x 160mm stem was packaged as a legion 10mm x 160 mm stem on the outer label. / Ltiquette extrieure sur lemballage dune tige de 20 mm x 160 mm fabrique par la socit Legion indique quelle est de 10 mm x 160 mm. A 46mm head was lasered and packaged as a 45mm head. Damaged batteries, 2 specific sequence of events lead to invalid infusion register state, faults in internal communications of pump, pump may short circuit due to fluid ingress or compromised insulation.
A) Brilliance CT Big Bore System - Main Unit B) Brilliance CT Big Bore System - Workplace Hemodialysis Blood Tubing Set Legion Press Fit Stems
Philips Medical Systems (Cleveland), Inc. Fresenius Medical Care North America Smith & Nephew, Inc.
2009-03-02 2009-03-02 2009-03-02
2009-02-11 46654 2008-11-27 45519 2009-01-23 46554
Type II Type II Type III
Tandem Unipolar 46mm Femoral Heads A) Colleague Volumetric Infusion Pump B) Colleague 3 Volumetric Infusion Pump C) Colleague Guardian Enhanced CXE Pump D) Colleague Guardian Enhanced 3CXE Pump E) French Colleague CXE Volumetric Pump F) French Colleague 3 CXE Volumetric Pump Pip Fixation Hinge Kit A) Advia 1650 Creatinine (CREA) Assay B) Advia 2400 Creatinine 2 (CREA_2) Assay C) Advia 1650 Creatinine (CREA) Assay D) Advia 1200 Creatinine 2 Assay (CREA 2) E) Advia 1800 Creatinine 2 (CREA_2) Assay F) Advia 1800 Creatinine (CREA) Assay G) Advia 2400 Creatinine (CREA) Assay
Smith & Nephew, Inc. Baxter Healthcare Corporation
2009-03-02 2009-03-02
2009-01-23 46556 2009-01-28 45280
Type II Type II
Smith & Nephew, Inc. Siemens Healthcare Diagnostics Inc.
2009-03-02 2009-03-16
2009-01-29 46558 2009-02-18 46691
Type II Type III
126646 A) 2M8151, 2M8161, DNM 8151 B) 2M8153, 2M8163, DNM 8153 C) 2M9161 D) 2M9163 E) DNM9163 F) DNM9163 101638 A) 03039070 B) 03039070 C) 03039070 D) 03039070 E) 03039070 F) 03039070 G) 03039070
08LM02210 A) All Serial Numbers B) All Serial Numbers C) All Serial Numbers D) All Serial Numbers E) All Serial Numbers F) All Serial Numbers 07DM13310, 08FM16961
Hinges are cracking/breaking pre-op, intra-op, and post-op causing loss of functionality of the product. Post-op failures have resulted in loss of distraction/reduction. A) 175572616, 175516116, 175518135, 176504- The reagent is not meeting the current on-board stability claims of 20 days without reagent container inserts in the new XL versions of software. 768, 175581661, CA17551062, 175592713, 175597-737, 175535293, 175535294, 175588693, 175516117, 175518134, CA17501263, 175528239, 175573189, 175542364 B) CA12420092, CA12420093, CA12430054, CA12430055 C) 175572616, 175581661, 175516116, 175518135, 176504-768, CA17551062, 175592713, 175597-737, 175535293, 175535294, 175588-693, 175516117, 175518134, CA17501263, 175528239, 175573189, 175542364 D) CA12240081, CA12240082, CA12220026 E) CA12340052 F) CA12340052 G) CA12420092, CA12420093, CA12430054, CA12430055 There is an incorrect radius in the taper of the 36mm -3 heads. This could result in the tapers not locking fully or properly on the stems, impingement and/or wear debris. Some tests of the GS HbsAg EIA 3.0 kit have been rejected during real time product stability testings: on high level, the optical density of the kit positive control was less than the lowest acceptable limit.
Oxinium Femoral Heads 36mm -3 GS HBsAg EIA 3.0
Smith & Nephew, Inc. Bio-Rad Laboratories, Inc.
2009-03-16 2009-03-16
2009-01-29 46557 2009-02-16 46713
Type II Type III
71343603 32591
> 10 Numbers, Contact Manufacturer 164CCC, 179CCC, 235CCC
Cell-Dyn Ruby With System Software V2.0 ML A) PCR Eleva S Plus B) PCR Eleva Corado Brilliance ICT System-System
Abbott Laboratories Diagnostic Division Philips Medical Systems DMC GMBH
2009-03-16 2009-03-16
2009-02-23 46767 2009-02-23 46769
Type III Type II
08H67-01 A) PCR Eleva S Plus B) PCR Eleva Corado 728306
N/A A) N/A B) N/A N/A
2009-03-16
2009-02-20 46770
Type II
Sealapex Xpress A) Universal Intra-Aortic Balloon B) Narrowflex Intra-Aortic Balloon C) 9FR Rediguard IAB Catheter D) 8FR 40cc Rediguard IAB Catheter E) 7FR 30cc Rediguard IAB Catheter Kit F) Ultra IAB Catheter Kit G) Arrow Driveline H) Ultraflex Intra-Aortic Balloon I) Ultra 8 IAB - Lightwave Sensor Zoll AED Plus Defibrillator A) Innova 2100IQ X-Ray Imaging System B) Innova 4100IQ X-Ray Imaging System Datex-Ohmeda AS/3 Anesthesia System A) Button Feeding Tube B) Button Replacement Gastrostomy Device A) Stardriver Screwdriver, T8, Manual B) Torque Limiting Attachment Web, Pocket And Cellular Viewers
Sybron Endo Arrow International, Inc.
2009-03-16 2009-03-16
2009-02-24 46779 2009-02-09 46517
Type II Type I
N/A A) IAB-04840-U B) IAB-04830-U C) IAB-R950-U D) IAB-S840C E) IAB-S730C F) IAB-05830-U, IAB-05840-U G) IAK-02691, IAK-02692 H) IAB-06840-U I) IAB-05830-LWS, IAB-05840-LWS N/A A) 2335129-4, 2335139-4 B) 2335129, 2335129-5, 2335139-2, S18741AM N/A A) 000256 B) 000292 A) 03.617.902 B) 03.110.002.99 M1057669
6-1314, 7-1221, 7-1258 A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer C) > 10 Numbers, Contact Manufacturer D) > 10 Numbers, Contact Manufacturer E) > 10 Numbers, Contact Manufacturer F) > 10 Numbers, Contact Manufacturer G) > 10 Numbers, Contact Manufacturer H) > 10 Numbers, Contact Manufacturer I) > 10 Numbers, Contact Manufacturer Serial Numbers Less Than X09B200000 A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer > 100 Numbers, Contact Manufacturer A) HUSD0351 B) HUSD0126 & HUSD1972 A) N/A B) N/A
CELL-DYN Ruby system (software V 2.0 ML only) mixer motor can exceed temperature specifications per certain safety standard, after cycling power to the analyzer. Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS. Artifact may appear if combination of 80KV and either a UA, UB or UC filter is used for reconstruction of the images, during brain scans and brain perfusion studies, in Brilliance iCT systems on software V2.5.0. Sealapex Xpress root canal filling material may contain crystals preventing gutta percha points from reaching bottom, which in turn may cause leakage and need for retreatment. Blue connector for 40cc IAB not properly recognized by IAB pump system. Fault in connector of pump tubing assembly may result in volume setting on pump defaulting to 2.5 or 5cc rather than 30,40 or 50cc.
Zoll Medical Corporation GE Healthcare
2009-03-16 2009-03-16
2009-02-14 46732 2008-09-09 43319
Type II Type III
GE Healthcare Finland OY Bard Access Systems, Inc. Synthes (Canada) Ltd.
2009-03-16 2009-03-16 2009-03-16
2009-02-19 44987 2009-02-10 46551 2009-02-12 46653
Following a long period (> 4 years) without use, a Zoll AED Plus Defibrillator may prompt "change batteries" during use and fail to deliver therapy. Defective battery charger caused the loss of the mains power and unit could not be turned back on. There is no monitoring to warn the user the battery voltage is low and is about to shut down. Patient breathing circuit or tubing of the anesthesia delivery unit (ADU) misconnects. Patient can not be ventilated.
Pin of feeding adaptors may not be aligned which create a restriction within the adaptor preventing food from getting through the occlusion.
GE Healthcare Finland OY
2009-03-16
2009-03-04 44728
Type II
Ventri Dual Detector Cardiac Camera
GE Healthcare
2009-03-16
2009-02-11 44732
Type II
N/A
Immucor Inc.
2009-03-16
2009-02-02 46515
Type II
87000
E.CAM PHS FOV
Siemens Medical Solutions USA, Inc. Molecular Imaging Group Abbott Laboratories Diagnostic Division
2009-03-16
2009-02-03 46563
Type III
4366618, 4381088
AxSym Sustem Tubing Decontamination Solution
2009-03-16
2009-02-24 46832
Type II
7A83-01
Periowave Photo-Disinfection System
Ondine Biopharma Corporation
2009-03-16
2008-11-25 46928
Type III
N/A
A) Advia 1200 Total Protein II (TP) Assay B) Advia 1800 Total Protein II (TP) Assay C) Advia 1650 Total Protein II (TP) Assay D) Advia 2400 Total Protein II (TP) ASSAY
2009-03-16
2009-03-03 47005
Type III
A) 01803350 B) 01803350 C) 01803350 D) 01803350
A) Fastrac "Pull" Gastric Access Port Kit B) Fastrac Guidewire Gastric Access Kit
2009-03-16
2009-02-11 46553
Type II
A) 005729 B) 005739
The labelling is being corrected on page 16 of the zero P instruments and implants technique guide. This is to ensure that surgeons always use the torque limiting attachment with the Stardrive screwdriver. Serial Numbers GB8717D5D4 and GB8747303C 1) Possible failure of CIC Pro Alarms. 2) Mobile care software/mobile viewers do not recognize Apexpro FH telemetry transmitter. 3) Mobile care software/mobile viewers and iCentral might generate false positive alarms. Serial Numbers 11259008, 11083011, Patient's hand squeezed in the gap between the table and the gantry. Patient suffered a 11200010, 11016014, 11016013, 11135012, hand cut that had to be sutured. 11135012, 00000000VEN004000, 11111018 N/A Windows does not allow creation of files with same name, differing only in case (which is possible with Echo software). Interpretation of last result written will be superimposed on with the first result written. > 10 Numbers, Contact Manufacturer Customer safety advisory notice regarding patient attempts to pull themselves up using the patient handling system field of view flip-up armrests without assistance, chance that fingers can get pinched. Bottle labels from lot 211974M AxSYM System Tubing Decontamination Solution (list 211974 number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date. N/A Manufacturer has determined that the recently manufactured Periowave Photo-Disinfection laser base stations supplied with the plastic base plate (PW1100) do not conform to the current EMC standard. Research and development studies determined that freshly opened reagent does not pass A) CA12250055, CA12250088, CA12260006, the Dextran Interference Specification. CA12240081, CA12240082, CA12260038, CA12220026 B) CA12330010, CA12330020, CA12320094, CA12330001, CA12310068, CA12310069, CA12300004, CA12320093, CA12340052, CA12320088, CA12320015, CA12320016, CA12310091, CA12320089, CA12310055, CA12310054 C) 175542364, 175535294, 175535293, CA17551062, CA176504-768, 175572616, 175581661, CA175588-693, CA12250055, 175516116, 175518135, 175573189, 175516117, 175518134, CA17501263, 175528239, 175592713, 175597-737 D) CA12430022, CA12430055, CA12440034, CA12440035, CA12440048, CA12440092, CA12420093, CA12430054, CA12440038, CA12440033 A) All Lot Numbers Premature balloon deflation when exerting excessive tightening of the external bolster, B) All Lot Numbers which could result in peritonitis and additional adverse conditions.
A) Aisys Anesthesia Carestation -Main Unit B) Aisys Anesthesia Carestation - Trolley C) Aisys Anesthesia Carestation D) GE Datex-Ohmeda Avance Anesthesia System E) GE Datex-Ohmeda Avance Anesthesia System Trolley
Datex-Ohmeda, Inc.
2009-03-16
2009-03-02 46656
Type II
A) 1011-9000-000 B) 1011-8302-000 C) 1011-8109-000 D) 1009-9002-000 E) 1009-8134-000
Swan-Ganz Continuous Cardiac Output
Edwards Lifesciences LLC
2009-03-16
2009-02-09 46971
Type II
744HF75, 746HF8
A) S/N'S ANAH001122 & ANAJ00132 B) > 10 Numbers, Contact Manufacturer C) S/N'S ANAJ00131, ANAJ00133, ANAK00110, ANAK00111, ANAK00112, ANAK00113, ANAK00114, ANAK00115 D) S/N'S ANBL01967, ANBL01990, ANBM00367, ANBH00291 E) > 100 Numbers, Contact Manufacturer > 100 Numbers, Contact Manufacturer
Failure of the electrical portion of the on/standby switch causes the system to shutdown without clinical intervention, causing the patient to experience hypoventilation leading to hypoxia.
Orthocord Violet Braided Composite Suture
Depuy Mitek
2009-03-16
2009-02-03 47042
Type II
223105
AP2546
Instrument Manager Instrument Manager A) Trigen Trochanteric Antegrade Nails B) Trigen Trochanteric Interlocking Nails Intertan Lag/Compression Screw Kit
Data Innovations Data Innovations Smith & Nephew, Inc.
2009-03-16 2009-03-16 2009-03-16
2009-02-17 47050 2009-02-17 47057 2009-02-27 46974
Type III Type III Type II
N/A N/A A) 7163-8232, 7163-8242, 7163-8336, 7163-8344 B) 71633130, 71633134 71677105
2009-03-16
2009-02-26 46975
Type II
Specimen Management Database Version 8.07 And 8.08 Specimen Management Database Version 8.07 Or Higher A) 08KM06602, 08KM08612, 08KM06604, 08KM07560 B) 08KM12411, 08KM12403 06GM11410
Cardiac output measurements were unavailable and the following fault message was displayed in vigilance monitors: "fault. CCO catheter verification use bolus mode" instead of continuous output mode. Unable to assure sterility due to a failure in the sterilization process. Subject suture was impacted by the same sterilization process failure reported for Vicryl, Monocryl and PDS II sutures in recall #46404. 'Any test is rerun' data element may not trigger a rule to fire even though a test is marked as a rerun in the specimen management database. Specimen management rules may fire inconsistently when evaluating tests using nested rules (parent/child). Product was distributed with non-compliant labelling. Label colour codes and graphics were left off of the outer labels. Screw kits were distributed containing 2 compression screws instead of 1 each of a compression screw and a lag screw. As this device is distributed in sterile packaging, the issue may not be immediately evident. The sample dilution low concentration flag for 1:101 automated dilution protocol fluid for the AxSYM AFP Assay file (3 0 100) on the device allows the instrument to report results between 0ng/ml and 0.4ng/ml. Two labels were left off package. Caution: device sale restricted to dentists and contains dry natural rubber. The outer packaging of dental impression material, Take 1 Advanced LB Wash Super Fast Set, has two contradicting labels: Light-Body Fast Set and Super Fast Set. The product contains Super Fast Set. The device exhibited characteristics that are inconsistent with the product specifications. In some cases, char and coagulum have been observed. Secondary package graphic label indicates wrong product (Fusion Extraction Balloon). All other package and internal labelling is correct. Certain Near Empty Flags, sold in Near Empty Flag Kits(0131-0122) and in Halfnut, Leadscrew & Flag Kits(0131-0236), for use in Graseby 3000 Syringe Pumps, may become dislodged rendering Near Empty Alert inoperable. Since issuing a recall in December 2008, Smiths Medical has found that one lot of keypads, in some fully assembled pumps and some kits, is predisposed to short circuits which can render the keypad inoperable. Defect associated with result viewer's "view assay" button in the "specimen history" screen. Laboratories using this feature, as well as a very specific sequence of events, may be impacted. There are no instructions on the package insert for the use of the pinch clamp that is an integral part of the Therasphere Administration Set. Beckman Coulter has confirmed greater variability, and low recovery values on at the low end of the therapeutic range (<1.5 ug/ml, <3.13 umol/l) with Synchron Systems Gentamicin Reagent (GEN) lot M804552. Images from two different patients may be combined in one patient folder in the digital imaging or may be combined as one (printed) image. The default ratio definition of the calculation for %HBAIC has been confirmed that the calculation is incorrect for Advia 1650, software version 4.01.01, and for Advia 1800, software version 1.01.01. Potential patient safety concerns, under certain conditions, involving patient jacket content, which may result in unintended historical image(s) being displayed. Following the release of the Omnifuse upgrade utility (recall #42817) it was discovered that the options to upgrade French and Dutch language pumps did not correctly install some language text into the pump. The previous patient history and some QA management reports may have missing or incorrect diagnosis text.
Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected.
Axsym Cancer Assay Disk Version 5.0
2009-03-16
2009-03-05 47105
Type III
03D50-05
N/A
Elements Gutta Percha Cartridge Take 1 Advanced LB Wash Super Fast Set
Sybron Endo Kerr Corporation
2009-03-16 2009-03-16
2009-03-06 47107 2009-03-06 47112
Type III Type III
N/A 33955
N/A 8-1182
Navistar RMT Diagnostic/Ablation Catheter Updated recall # 41193 previously posted on 200803-17. Fusion Oasis One Action Stent Near Empty Flags
Biosense Webster Inc.
2009-03-30
2008-02-28 41193
Type I
NR7TCSIY
All Lot Numbers
Wilson-Cook Medical, Inc. Smiths Medical MD Inc.
2009-03-30 2009-03-30
2009-02-24 46763 2009-03-05 47084
Type II Type II
FS-OA-10 0131-0122, 0131-0236
CFW462190 Contact Manufacturer
A) Medfusion Syringe Infusion Pumps B) Medfusion Keypads C) Medfusion Top Case Assembly Specimen Gate Laboratory
Smiths Medical MD Inc.
2009-03-30
2009-03-05 47083
Type II
Wallac OY
2009-03-30
2009-01-15 47157
Type II
A) 3500-306, 3500-415 B) G6000607, G6000771 C) G6000737 5002-0180
A) > 10 Numbers, Contact Manufacturer B) P120300, P121344, P127163 C) M59050, M59505, M60280 Version 1.2 REV2, Version 1.3
Therasphere Administration Set Synchron Systems Gentamicin Reagent
MDS Nordion Beckman Coulter Inc.
2009-03-30 2009-03-30
2009-02-23 46822 2009-03-09 47011
Type II Type II
990226.SPE 469137
N/A M804552
A) Multidiagnost Eleva B) Omnidiagnost Eleva A) Advia 1650 B) Advia 1800 Centricity PACS Workstation - Software Omnifuse PCA Syringe Pump
Philips Medical Systems Nederland B.V. Siemens Healthcare Diagnostics Inc.
2009-03-30 2009-03-30
2009-03-09 47191 2009-03-09 47200
Type II Type III
GE Healthcare Integrated IT Solutions Smiths Medical MD Inc.
2009-03-30 2009-03-30
2009-01-22 46162 2009-01-27 46274
Type II Type III
A) 70832 B) 708027 A) 06363413, 073-B002-01, 10324237 B) 01412173, 02416873, 073-A021-01, 10315183 N/A 0153-0711
A) N/A B) N/A A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer > 100 Numbers, Contact Manufacturer N/A
SoftPath GUI v. 4.2.3.4,4.2.4.1,4.3.0.4
SCC Soft Computer
2009-03-30
2009-01-26 46600
Type II
Syngo Dynamics Workstation Software Syngo Imaging C.S.A.N. AED 10 MRS Cemented Stems
Siemens Medical Solutions USA, Inc. Siemens AG Welch Allyn Protocol, Inc. Howmedica Osteonics Corporation
2009-03-30 2009-03-30 2009-03-30 2009-03-30
2009-02-05 47063 2009-02-11 47068 2009-02-26 47076 2009-03-05 47104
Type III Type III Type I Type II
GUI VERSION 4.2.3.4, GUI VERSION 4.2.4.1, GUI VERSION 4.3.0.3, GUI VERSION 4.3.0.4 100 90 597, 100 90 599 10 014 063 970300, 970302E, 970308E, 970309-E, 970310E, 970311E, 970311U 6485-3-010, 6485-3-018, 6485-3-019
N/A
> 10 Numbers, Contact Manufacturer 1200 > 10 Numbers, Contact Manufacturer TEC231A, TEC077, TEC078B
Customer safety advisory notice to inform customer of potentially defective stored image data on long term storage. Problems with the AED 10 defibrillator: 1. Low energy delivery 2. Blown fuse 3. Loss of voice prompt 4. Electromagnetic noise filtering 5. Shutdown. There are no warnings on the label or IFU that the 8, 9, 10mm diameter MRS Cemented Heads should only be used with the GMRS Distal Femoral Components and the GMRS Proximal Tibial Components.
ILED Surgical Lighting Systems
Trumpf Kreuzer Medizin Systeme GMBH & Co. KG
2009-03-30
2009-03-16 47210
Type II
ILED3, ILED5, ILED5K
100268621 to 100717475
Symbia T, T2, T6, T16
Siemens Medical Solutions USA, Inc. Molecular Imaging Group
2009-03-30
2009-02-26 47218
Type II
10275007, 10275008, 10275010
1056, 1012, 1058
The cover plates on these surgical lights can be damaged by certain disinfectants. Cracks can form around the screw connections of the cover plates and the material can become brittle and fragments break off. The pinion gear could crack and may cause damage to the systems. Damage to the pinion gear may cause the gantry to spin freely. Replacement of the pinion gear is mandatory. The manufacturer has noticed an increase in the number of complaints of snare (loop) detachment from the device.
A) Disposable Singular Polypectomy Snares B) Disposable Optimizer Polypectomy Snare C) Entake Peg Push Safety Kit D) Entake Peg Pull Safety Kit E) Entake Peg Push Standard Kit F) Entake Peg Pull Standard Kit
Conmed Endoscopic Technologies, Inc.
2009-03-30
2008-12-04 45614
Type II
Linear Accellerators
Siemens Medical Solutions USA, Inc. Oncology Care Systems
2009-03-30
2009-02-26 47066
Type III
A) 000957, 000958, 000959, 000960, 000963, 000964, 000965, 000977, 000978, 000979, 000980, 000983, 000984, 000985, 000986, 000987, 000988, 000991, 000992 B) 000460, 000461, 000462, 000463, 000464, 000465, 000466, 000467, 000472, 000473, 000474, 000475, 000476, 000477, 000478, 000479 C) FESG20ND D) FESP20ND E) FEXG20ND F) FEXP20ND 1940035, 4504200
A) 0605011 Through/Including 0805311 B) 0605011 Through/Including 0805311 C) 0605011 Through/Including 0805311 D) 0605011 Through/Including 0805311 E) 0605011 Through/Including 0805311 F) 0605011 Through/Including 0805311, 0807161 Through / Including 0811202
3235, 3236, 3356, 3645
Acuson S2000
Siemens Medical Solutions USA, Inc.
2009-03-30
2009-02-24 47069
Type III
10041461
200288, 200583, 200591, 200593, 200599, 200252, 200334
Safety advisory letter concerning the apparent inconsistency in the direction of gantry rotation during an auto-sequenced delivery, affects when using console versions CC6.2 through CC9.1. 1. Data framing an image could be leftover from a previous patient and may or may not include measurement results.2. If the last image stored is an elastogram, it may appear as the first image of the next patient.
A) Alumina Ceramic Femoral Head 28mm B) Alumina Ceramic Femoral Head 32mm
Zimmer Inc.
2009-03-30
2009-02-23 47128
Type II
A) Radiolucent Spine Reference Clamp Kit B) Radiolucent Spine Reference Clamp A) Darco 2.5 Cannulated Hex Screwdriver B) Wright Express Kit Architect Reaction Vessels Truncated Blade I-STAT EG7+ Cartridges Flow-Set Fluorospheres
Brainlab AG
2009-03-30
2009-02-03 46474
Type II
A) 00-6428-028-01, 00-6428-028-02, 006428-028-03 B) 00-6428-032-01, 00-6428-032-02, 006428-032-03 A) 55757 B) 55756 A) DC4261 B) DMRSKIT1 7C15-01 00-7053-058-10 N/A 6607007
A) All Lot Numbers B) All Lot Numbers
Labelling will be changing to indicate that these heads should not be combined with Zimaloy hip stems made from castings. Labelling for the applicable case Zimaloy/cobalt-chrome hip stems will also be changed. A combination of Spine Reference Clamp(55756) with any other array or extension then the intended array(55753), allows for rotation of the reference array even though the mounting nut is tightly closed. 2 of 3 sterilization methods (by gravity displacement) listed in package insert for Darco Cannulated Hex Screwdriver, sold alone and as part of the Wright Express Kit, haven't been validated for this instrument. Reaction Vessels manufactured from a specific lot of resin have an increased likelihood of producing error code 1006, error code 1007 and incorrect patient results. The catalogue number etched on the instrument reads "7053-58-20" and it should read "7053-58-10". The incorrect catalogue number corresponds to full blade. Certain boxes of i-STAT EG7+ Cartridges have sub optimal pouch seals. There is the possibility that the performance of the cartridge assay may be impacted. Current flow set labelling does not provide new target settings for tetra applications.
A) N/A B) 6001607001 A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer > 50 Numbers, Contact Manufacturer 60682170 P08274A 7524003F, 7524004F, 7524005F, 7524006F
Wright Medical Technology Inc.
2009-03-30
2009-02-19 46951
Type III
Abbott Laboratories Diagnostic Division Zimmer Trabecular Metal Technology, Inc. Abbott Point Of Care Inc. Beckman Coulter Inc.
2009-03-30 2009-03-30 2009-03-30 2009-04-13
2009-03-04 47027 2009-03-12 47373 2009-02-23 47216 2009-03-16 47347
Type III Type II Type II Type II
A) Percutaneous Sheath Procedural Kits B) Central Venous Catheterization Set/Kit C) Temporary Pacing Catheter D) Two-lumen Central Catheterization Kit E) Percutaneous Sheath Introducer Sets F) Stopcocks G) Arterial Access Products H) Thrombolic Device Rotator Drive Unit I) Tretorola Percutaneous Thombolic Device J) Percutaneous Sheath Introducer K) Super Arrow-Flex Percut Sheath Intro L) Stopcock with Luer Lock M) Stopcock Manifold N) Multi-Lumen Percut Sheath Introducer O) Stopcock with Luer Lock P) Stopcock with Luer Lock Q) Blood Administration Sets R) Extension Sets S) Trerotola Percut. Thrombolytic Kit
Arrow International, Inc.
2009-04-13
2009-02-18 46908
Type II
Access Systems Total BHCG Reagent Kit
Beckman Coulter Inc.
2009-04-13
2009-03-16 47348
Type II
A) Contact Manufacturer A) AK-09903-J, CA-09803, CA-09886, CA-09903-LF, RV-09803, SB-09803, SB- B) Contact Manufacturer C) Contact Manufacturer 09883-S, SB-09907-S, SP-09801 D) Contact Manufacturer B) AK-14703-J, AM-15703-J E) Contact Manufacturer C) AI-06210-IK, AI-7155-IK F) Contact Manufacturer D) AK-17702-J E) CL-07011, CL-07024, CL-07045, CL- G) Contact Manufacturer H) Contact Manufacturer 07065, CL-07080, CL-071165, CL071180, CL-07511, CL-07524, CL-07545, I) Contact Manufacturer J) Contact Manufacturer CL-07590, CL-07611, CL-07624, CL07635, CL-07645, CL-07665, CL-07690, K) Contact Manufacturer L) Contact Manufacturer CL-07700, CL-07711, CL-07724, CL07735, CL-07745, CL-07765, CL-07780, M) Contact Manufacturer CL-07790-R, CL-07800, CL-07824, CL- N) Contact Manufacturer 07835, CL-07845, CL-07880, CL-07924, O) Contact Manufacturer P) Contact Manufacturer CL-07965, CL-07980, CP-07011, CP07511, CP-07611, CP-07711, CP-07811, Q) Contact Manufacturer R) Contact Manufacturer CP-07911, CR-07645, CR-07745 S) Contact Manufacturer F) SC-00001, W-15549, W-19922 G) AA-00611, AA-15511, AA-15511-S, AA-15611, AA-15611-S, AA-15624 H) PT-65509-HFC I) PT-45509 J) CA-09801, CA-09807, MTO-09801CHA K) CL-08403, CL-08503, CL-08503-A, CL08603, CL-08605, CL-08605-HF, CL08703, CL-08705-HF, CL-08803, CP08403, CP-08503, CP-08603, CP-08603P, CP-08703, CP-08803, CP-08903, CW08703, CW-08803, IC-09880 L) W20041 33500 824542, 825652
Material used in the manufacture of these products is not lipid resistant and could be weakened during the administration of lipid solution.
1550 Electric Stetcher With Quick Drop
Stryker Medical
2009-04-13
2009-03-16 47353
Type II
1550-000-000
C2A Ringloc Acetabular System - 28 mm Bard Max-Core Disposable Biopsy Instr. Hill ROM Totalcare Bed Norwex Silvercare Toothbrush
Biomet Orthopedics, Inc. Bard Peripheral Vascular, Inc. Hill-ROM Company, Inc. Norwex Enviro Products Inc.
2009-04-13 2009-04-13 2009-04-13 2009-04-13
2009-03-16 47389 2009-03-09 47251 2009-03-09 47219 2009-03-17 47238
Type II Type II Type II Type II
12-115112(RD115112) MC1810, MC1816, MC1820 N/A 22963
A) Option + Sterile PADS 5cm X 5cm B) Option + Steriles PADS 10cmX10cm A) Heparin pre-filled syringes B) Saline pre-filled syringes Byrd Screw 2.0x6mm Self Drilling 5/0 Polyglycolic Acid Absorbable Suture
Uniprix Inc. Medxl Inc.
2009-04-13 2009-04-13
2009-03-13 47475 2009-03-29 47632
Type III Type II
Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation Ace Surgical Supply Co. Inc.
2009-04-13 2009-04-13
2009-02-20 46721 2009-02-24 47393
Type II Type II
A) 771290064484 B) 771290064491 A) 3706, 3780, 3781, 3786, 3787 B) 3704, 37043, 37043B, 37043BNC, 3705C, 3705NC, 3706 01-0267 34630
There is an increase in background relative light units (RLU) when comparing results between when a pack is first mixed/loaded and after it has settled on the instrument for 10 hours or more. This may produce a shift in results. > 100 Numbers, Contact Manufacturer Stretcher fowlers (backrests) may develop a grinding noise from wear of drive nut threads in the fowler. If the stretcher continues to be used, the fowler may inadvertently drop to its lowest (flat) position. All Lots Possibility of ceramic heads fracturing with +5mm offset. RESH0255, RESH0057, RESH0736, RESI0279, Incorrect label. Label indicates a length of sample notch of 1.9cm (19mm), where actual RESI0451 product is 1.8cm (18mm), a potential difference of 1mm in length. J329AMXXX to J340AM1369 E-ring may not fully be seated on the siderail bracket. It could cause the e-ring to be missing and could result in an inability to latch the siderail. N/A Toothbrush head may pose a choking or swallowing hazard to children under three years of age or to individuals that would normally require supervision or assistance brushing their teeth. A) 10380, 10381 Some sterile pads that had not been sterilized were released for sale. B) 10381 A) All lots between 6892 and 8180 Complaints received about discolouration and particulate matter contamination. B) All lots between 6892 and 8180 91807107 081031-07 The 01-0267 Byrd screw may break when being used. A small and limited number of packaged product demonstrated a partial delamination, or coming apart, of the two layers of material that make up the clear portion of the outer packaging.
Packaging test logs indicate burst test results fell below validation parameters. There may be deterioration of short or long term packaging integrity (inner or outer) with potential loss of sterility.
Restoration Modular Cone Bodies Percutaneous Combination Stent
Howmedica Osteonics - Stryker Ireland Boston Scientific Corporation
2009-04-13 2009-04-13
2009-03-27 47576 2009-03-23 47581
Type II Type II
6276-1-121, 6276-1-125, 6276-1-219, 6276-1-325 410-111, 410-112, 410-126, 410-202, 410-203, 410-204, 410-205, 410-206, 410-207, 410-304, 410-305 010-1619-00, 010-1655-00
22125701, 21834602, 21883201, 21883401 > 100 Numbers, Contact Manufacturer
During the attempted removal of the device, sutures were separated from the catheter and remained in the patient. In one instance surgical intervention was opted to remove a suture. The external power supply used with certain models of the Spacelabs Medical 19" flat panel displays may fail prematurely, causing the display to go blank. Audio alarms continue to function normally. A metabolite of naproxen, O-desmethylnaproxen, has demonstrated a positive interference with the Jendrassik-Grof method of measuring Total Bilirubin, leading to spurious elevation in Total Biliruben levels. The Phosphorus Reagent (PHOSm) may fail calibration approximately three to six days after loading on some Synchron systems. The foil wrapper for specific lots of slide cartridges may have been damaged during the packaging process. Exposure of slides to uncontrolled environmental conditions could impact performance.
Medical Flat Panel Power Supply
Spacelabs Medical, Inc.
2009-04-13
2009-03-25 47582
Type II
0647, 0703, 0706, 0707, 0709, 0712, 0724, 0727, 0728, 0732 N/A
Synchron System Total Bilirubin Reagent
2009-04-13
2009-04-06 47692
Type III
442745, 476861
Synchron Phosphorus (PHOSm) Reagent A) Vitros Chemistry Slides - Creatine B) Vitros Chemistry Slides - Enzymatic CO2 C) Vitros Chemistry Slides - CSF Protein D) Vitros Chemistry Slides - Total Bilirubin
Beckman Coulter Inc. Ortho-Clinical Diagnostics Inc.
2009-04-13 2009-04-13
2009-04-06 47693 2009-03-31 47712
Type III Type III
467868 A) 680 2584 B) 8262396 C) 8208431 D) 8159931
M808353, M808354
Coronary Scissors 7"
Teleflex Medical
2009-04-13
2009-03-09 47208
Type II
352164, 352165, 352166, 352167, 352168 6079300, 6079391, 6079433, 6150614, 6424704, 6424779 C1410A, C1810B, C1813B, C1816B, C1820B, C2013B, C2016B, C2020B MMT-377600, MMT-378600, MMT381600, MMT-382600 SXR0602021, SXR0602025 3610195001
Date Codes RR8, SS8, TT8, UU8, VV8, WW8, XX8, MM9. > 10 Numbers, Contact Manufacturer
Servo 300
Maquet Critical Care AB
2009-04-13
2009-03-27 47623
Type II
Truguide Coaxial Biopsy Needle
Bard Peripheral Vascular, Inc.
2009-04-13
2009-04-01 47695
Type II
> 10 Numbers, Contact Manufacturer
Paradigm Silhouette Infusion Sets
Unomedical A/S
2009-04-13
2009-04-01 47734
Type II
617095, 616520, 616521, 617090, 617094, 616522, 617089, 617093, 616523 073008100, 062608322 All Lots
GT Series X Factor II (Prothrombin) G20210A Kit
Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics Roche Molecular Systems, Inc
2009-04-13 2009-04-27
2009-03-30 47759 2009-04-06 47434
Type III Type III
Delfia Xpress PAPP-A A) IV Set with Universal Spike, 2 Ultrasite B) Primary IV Set with 3 Ultrasite A) Grieshaber Handpiece, MPC Microscissors B) Vertical Scissors Update Recall # 35431 previously posted on 200706-11. A) Magic Store System B) Sienet Magicstore A) Syngo Dynamics SD 6.0 Server Software B) Syngo Dynamics SD 6.0 Workstation Software A) Cell-Dyn 3700 SL Analyzer B) Cell-Dyn 3700 CS Analyzer Holter Neogram Amino Acids Mass Spec Kit
Wallac OY B. Braun Medical Inc. Alcon Grieshabe AG Siemens AG
2009-04-27 2009-04-27 2009-04-27 2009-04-27
2009-03-26 47713 2009-03-27 47750 2009-04-06 47782 2007-05-24 35431
Type III Type II Type II Type III
6003-0020 A) 352049/CSP152VSL B) 352049, 375100 A) 705.52 B) 704.52 A) 10 014 142, 10 014 154, 10 014 155 B) 8462645
510998, 515079, 511590 A) 61028769, 61028767 B) 61029904, 61029908 A) F53125, F58670, F65194, F67471, F69429 B) F61426, F63004 A) 3901384286 B) 3904116228, 3904115986
Manufacturing defect consisting of a rough square finish to the scissor tips, rather than a smooth rounded point, may cause damage to the inner wall of the blood vessel, rendering it unsuitable for bypass graft. Printed circuit boards have stopped working, results in expiratory valve staying in the open position, sometimes preceded by a short valve closure. Remote hazard of serious adverse health consequences. Black circle on pouch label for C2013B stated "for use with Bard MaxCore or Monopty Instruments", instead of "for use with MAGNUM Instruments and Biopsy Needles or Biopty Instrument and Biopty-Cut Needles". A typographical error in the fixed prime volume listed in instructions for use. IFU tells users to fill empty space in the cannula with a fixed prime volume of 0.3 units of U-100 insulin, instead of 0.7 units. 25mm length files were mislabeled as 21mm (SXR0602021), and 21mm length files were mislabeled as 25 mm (SXR0602025). The macro component intended to be used with the Factor II G20210A Kit for LightCycler 2.0 instrument may erroneously identify the C20209T mutation as a wild-type genotype instead of an unknown genotype. Some tracer bottles in the Delfia Xpress PAPP-A kit have bar codes which cannot be read in the Delfia Xpress instrument. Investigation for occlusion/no flow identified that disks involved in the low pressure check valve to have not been polyisoprene coated. New metal cannula assemblies are scheduled for launch in June 2009. These new metal cannula may have a tolerance stack up issue with selected lots of these scissors. Hardware component is near end of expected life cycle and the RAID Controller can cause a system crash resulting in a loss of data.
2009-04-27
2009-02-03 46562
Type III
A) 100 90 370, 100 90 480 B) 100 90 257 A) 02H31-01 B) 02H30-01 1810, 2010+ 3026-0010, 3026-0030
A) 95243, 92241, 95248, 93901 B) 93477 A) All Serial Numbers B) All Serial Numbers N/A Contact Manufacturer
Abbott Laboratories Diagnostic Division Philips Medical Systems Wallac OY
2009-04-27 2009-04-27 2009-04-27
2009-04-01 47694 2009-03-30 47704 2009-04-01 47714
A) Combi Sling B) Combi Sling Deluxe Child C) Combi Sling Mesh Deluxe Child D) Combi Sling Deluxe Oversize E) Combi Sling Mesh Deluxe Oversize F) Combi Sling Oversize Heavy Duty G) Combi Sling Mesh Deluxe A) Sterrad 50 Sterilizer System B) Sterrad NX Sterilizer System TD-Synergy Software On TD-Microbiology Heartstart XL Heartstart MRX Defibrillator / Monitor
BHM Medical Inc.
2009-04-27
2009-04-03 47789
Type II
Advanced Sterilization Products, A Division Of Ethicon
2009-04-27
2009-03-13 47825
Type II
A) 626002 B) 626002C C) 626002C-M D) 626003 E) 626003M F) 626003X G) 626002M A) 10050 B) 10033 TD-SYN-01 M4735A M3535A, M3536A
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer N/A S/N US00442485 to US00469873 S/N US00210406 TO US00333123
There is potential issue in the syngo Dynamics 6.0 reporting system. Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected. There have been occurrences of visible fire and smoke from the analyzer. They may contain the incorrect fuse for the electrical configuration at the customer site. Holter software version 2.9 and 2.9.1 may contain problems which could affect its performance. The truncated V-Bottomed Microplates delivered as a package of 10 plates may have occasional contamination which results in an apparent elevated C4 concentration in an affected well. A premature failure of the stitching at the junction of the shoulder strap and the sling body can lead to the detachment of the shoulder strap resulting in possible patient fall.
Technidata S.A.S. Philips Medical Systems Philips Medical Systems
2009-04-27 2009-04-27 2009-04-27
2009-04-02 47834 2009-04-09 47915 2009-04-09 47916
Type I Type II Type II
The Sterrad 50 system may potentially have defective oil fill plugs. Degradation of the nylon 6-6 plugs over time, if exposed to hydrogen peroxide, can contribute to emission of oil mist from the sterilizer. MIC (Minimum Inhibitory Concentration) result interpretation can be corrupted and an antibiogram could be reported as sensitive instead of resistant or vice versa.
The rotary energy switch may fail and prevent the user from turning the device on, rendering it unusable for monitoring and defibrillation therapy. The failure may also occur by spontaneously powering on.
The therapy switch has a small potential to fail. Most likely failure mode is spontaneous turnon which could deplete the battery, rendering the device unstable until power is restored. Product recall due to the possibility that the device tip could break during use. This recall is the result of reports of leaks at the blood filter of the Haemonetics lN620 PCS2 Plasma Harness Set.
Philips Bougies List No. 620 PCS2 Harness Set
Coloplast A/S Haemonetics Corporation
2009-04-27 2009-04-27
2009-01-23 46373 2009-04-13 47918
Type II Type III
AG55XX 00620-00
Wizard Replacement Gastrostomy Device
2009-04-27
2009-01-16 46066
Type II
A) Cognis CRT-D HE B) Cognis CRT-D C) Teligen ICD (VR-HE DF1) D) Teligen ICD (DR-HE IS-1) A) Contak Renewal 4 CRT-D B) Vitality 2 Acid Leckey Four-Point Pelvic Harness
Cardiac Pacemakers Incorporated
2009-04-27
2009-04-03 47936
Type II
Cardiac Pacemakers Incorporated Leckey (James Leckey Design)
2009-05-11 2009-05-11
2009-03-04 47031 2009-04-15 47922
Type II Type II
00201W, 00202W, 00204W, 00205W, 00207W, 00214W, 00215W, 00223W, 00224W A) N106 B) N107 C) E102 D) E110 A) H-190, H-197, H-199 B) T165, T167, T175, T177 122-719
All Manufactured Between 2003-2008 LN 081219511 and 081219512, LN 081222510 and 081222511, LN 081223510 and 081223511, LN 081224510 to 081224512 > 10 Numbers, Contact Manufacturer
Difficulty inserting or removing the feeding adapter cannula into the device.
A) N/A B) N/A C) N/A D) N/A A) N/A B) N/A LEC/019910-LEC/043681
Right ventricular lead complications may cause additional over-sensing ,thereby increasing the probability of inappropriate therapy.
Potential for reduced ERI to EOL time in a subset of implantable defibrillators, due to degradation of a low-voltage capacitor. The central plastic buckle degrades and can fail in use. The belts are used in the James Leckey seating systems: mobile advance seat, contoured advance seat, squiggles early sitting system, squiggles saddle seat.
A) Endopath Endoscopic Linear Cutters B) Endopath Endoscopic Linear Cutters C) Endopath Endoscopic Linear Cutters Eccentric Bushes In-Situ Bender/Cutter Synchron Systems Ammonia (AMM) Reagent A) Somatom Definition B) Somatom Definition AS
Ethicon Endo-Surgery, LLC
2009-05-11
2009-04-08 47966
Type II
Kaltenbach & Voight GMBH Synthes (Canada) Ltd. Beckman Coulter Inc. Siemens AG
2009-05-11 2009-05-11 2009-05-11 2009-05-11
2009-01-18 47039 2009-04-09 47833 2009-04-08 47835 2009-04-14 47910
Type III Type II Type II Type III
A) LONG45A B) ATB45, ATW45 C) NAW45 0.535.4692 530.521S, 530.522S 439770 A) 77 40 769 B) 8098027
A) E4MM23, E4MP4A, E4MT4Y B) E4MH2L, E4MG9M, E4ML6J, E4MH18 C) E4MJ3K, F4MX8C, F4N799 N/A All Lots M808278 A) 60148, 60199, 60206, 60235, 60332, 60348, 60422 B) 64032, 64049, 64052, 64069, 64137, 64141, 64233, 64238, 64306, 64316 Software V.4.0, Software V.3.0
The mechanism which connects the articulation joint to the device shaft may be insufficient. This may cause the jaws of some of the affected Endoscopic Linear Cutters to remain closed and clamped down on tissue. A nonconformance with the Eccentric Bushes can result in a rough surface that will result in altered revolutions per minute(RPM) and the lifetime of the device. During examination of shelf life samples as part of real time shelf life validation, the company became aware of and confirmed a breach of the sterile pouch barrier. The ammonia reagent may fail calibration or cause a low shift in quality control recovery (may recover below the limits of the established range) on some Synchron systems. Update the software on bugfixes (i-triggered sequence, bolus monitoring, 3D recon, reconstruction of raw data, 3D intervention, patient delete, AW hangup), kernel changes, graphic driver, and Microsoft hotfix. If a sample is manually loaded to the access 2I and no program is at the access 2I or DXC console, a program is sent by the LIS only to the DXC console and the sample will not be processed at the access 2I. The Vumax Ophthalmic Ultrasound System may, under certain circumstances, return measurement values on the order of 1/2 or 2x the actual value. Root cause is a software conflict within software version V2.0.06E.
Unicel DXC 600I Synchron Access Systems
2009-05-11
2009-04-14 47926
Type III
A27318
Vumax Ophthalmic Ultrasound Scanner
Sonomed Inc.
2009-05-11
2009-04-13 47987
Type II
SHFS35-S
Proultra Surgical Endo Tip A) Alaris PC Unit B) Alaris PCA Module Acuson X300 PE Swiftlink
Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics Cardinal Health 303, Inc.
2009-05-11 2009-05-11
2009-04-06 48008 2009-03-10 47844
Type III Type III
PUSURG1 A) 8015 B) 8120 10348531
3550-0207-0178, 3550-0108-0244, 3550-02070177, 3550-0408-0258, 3550-0707-0213, 35500707-0215, 3550-0708-0271, 3550-0907-0220, 3550-0908-0277, 3550-0908-0278, 3550-01080252, 3550-0207-0179, 3550-1106-0147, 35501106-0148 121808304 A) >1000 Numbers, Contact Manufacturer B) >1000 Numbers, Contact Manufacturer 313288, 313171, 313273
Prototype tips were mistakenly distributed to customers. Potential risk when the Alaris PCA Module is used with the Alaris PC Unit. The Alaris PCA Module can potentially infuse above or below the intended infusion dose for a specific sequence of events. Swiftlink adapters manufactured prior to October 2008 can cause a failure that results in image quality when using Acunav catheter transducers that does not support intra-cardiac diagnosis or procedure guidance.
In rare instances, the system does not turn the x-rays off at the end of a DXA scan. The "x-ray on" indicator light remains on, but an audible signal and the computer screen indicate the x-ray is off.
2009-05-11
2009-04-07 47911
Type III
A) Discovery X-Ray Bone Densitometer B) Explorer X-Ray Bone Densitometer
Hologic, Inc.
2009-05-11
2009-04-17 47998
Type II
Lifepak 12 Defibrillator / Monitor Focal Software CD Washer Didinfector Getinge 9027 - 9100
Physio-Control, Inc. Computerized Medical Systems Getinge Disinfection AB
2009-05-11 2009-05-11 2009-05-11
2009-04-09 48000 2009-04-09 48015 2009-04-20 48035
A) DISCOVERY-A, DISCOVERY-C, DISCOVERY-CI, DISCOVERY-W, DISCOVERY-WI B) EXPLORER LP 12 Focal SIM 9027, 9100
A) S/N: 83232, 83336, 83760, 83792, 83024, 82888, 83053, 83318, 83576 B) SN 91129 >10 Numbers, Contact Manufacturer N/A N/A
Integra CEM
Premier Dental Products Company DBA Premier Medical Medmont PTY Ltd.
2009-05-11
2009-03-25 48059
Type II
3001410
All Lots
A) E300 Corneal Topographer B) DV2000 Digital Imaging Software C) M700 Automated Perimeter Quickie LXI Manual Wheelchair
2009-05-11
2009-03-10 45746
Type II
Sunrise Mobility Products Division
2009-05-11
2009-02-02 47380
Type II
A) N/A B) N/A C) M700 LXI
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer LXI-034741, LXI-034609, LXI-034740, LXI034500 N/A
Affected defibrillator /monitors may have a solder defect on the H bridge component that could prevent the device from providing a defibrillation shock. Setup reference point incorrectly defined for prone patients when manual shifts are used. The frame earth of the supply transformers for Getinge 9100 and 9027-series Washer Disinfector have burnt out. Result from investigation shows poor connection between incoming and outgoing Protective Earth. Sale or distribution of the Integra CEM (item #3001410) is in violation of the medical devices regulations. The Integra CEM is not licensed as required per section 26 of the medical devices regulations. Unlicensed class II medical device.
Gallileo Echo Blood Bank Analyzer
Immucor Inc.
2009-05-11
2009-04-02 47888
Type II
87000
Infinity Glucose Hexokinase Reagent Acuson S2000
Fisher Diagnostics, A Division Of Fisher Scientific CO, LLC Siemens Medical Solutions USA, Inc.
2009-05-11 2009-05-11
2009-04-09 47989 2009-04-14 48076
Type II Type III
TR15498 10041461
V28015 200252, 200926, 200979, 200995
SmartMonitor 2 Infant Apnea Monitor
Respironics Inc.
2009-05-11
2009-04-27 48114
Type II
4002, 4003
S/N: 3000033364 to 3000038740
Insight Rev H Software-GI Motility System
Sandhill Scientific Inc.
2009-05-25
2009-02-23 47672
Type III
S98-1925-2H
All Lots
Medline Penrose Drain
Medline Industries Inc.
2009-05-25
2009-04-21 48072
Type II
Acuson S2000 VA10
2009-05-25
2009-04-14 48077
Type II
DYND50420, DYND50421, DYND50422, 05AA0001-09CA9999 DYND50423, DYND50424, DYND50425, DYND50426 10041461 200334, 200288
VGM 19" Monitor
Viewsonic Corporation
2009-05-25
2009-04-21 48079
Type II
VG930M
S/NS > QC2082880001
Stabilizer bar was inadvertently omitted from the configuration due to a system error. Stabilizer bar adds rigidity to the back to reduce head movement should the chair be involved in a vehicular collision. Incorrect patient demographic information could be associated with a sample ID. This only occurs when manually ordering an assay using the run test wizard on instrument with bidirectional interface capability. Failure of product to meet the stated performance specifications for shelf life, resulting in linearity of less than the stated specifications. When performing a tee exam with the V5MS Transducer, CW (continuous wave) mode is not functional. A waveform signal cannot be detected. This event occurs on every attempt to acquire a CW signal. A variation in the monitor manufacturing process could expose wires to potential short circuit of the wire leading to the alarm module. This can result in a situation where the alarm will not sound. In HRIM or EFT, patients with non-transmitted esophageal contractions that have been acquired with this software, the report may incorrectly report the esophageal contraction results. A drain placed by a surgeon and an x-ray ordered, the drain did not show up on x-ray although the packaging states the product is x-ray opaque. Two lots of product are affected in this issue. A series of events could cause the last image to be stored with the next new patient performed, L Teslia Mass 2 measurement label appears in the report in English only, more than 4 measurements may print. 48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel.
Derma Prene Ultra Surgical Glove
Ansell Healthcare Products LLC
2009-05-25
2009-05-04 48229
Type II
851365, 851470
0810006605, 0810006705
Some gloves may be discoloured as a result of film degradation. This degradation results in film strength properties below the ASTM performance standard for surgeon's gloves. Reports received that when the battery pack is first installed in pump, the pump will not power up or an alarm sounds and an error message displays indicating that battery pack is unusable and pump will not run. To inform our customers of a potential software problem with the Acuson Sequoia Ultrasound System that may result in overheating of the auxiliary 2 mHz continuous wave (CW) transducer.
CADD-SOLIS Rechargeable Battery Pack
2009-05-25
2009-04-30 48233
Type III
21-2160-51
>10 Numbers, Contact Manufacturer
A) Acuson Sequoia 512 Ultrasound System B) Acuson Sequoia C512 Echocardiography System C) Acuson Sequoia C512 Echocardiography System D) Acuson Sequoia 512 Ultrasound Accu-Chek Spirit Insulin Pump
2009-05-25
2009-04-02 47909
Type III
A) 82 45 875 B) 8255412, 8267697 C) 10038242 D) 10038241 04540492001, 04759702001, 04759729001 1539
Disetronic Medical Systems AG
2009-05-25
2009-04-17 48163
Type II
A) 53736, 54558, 55331, 61377, 63210 B) 53418, 57395 C) 68153, 68211, 68217, 68328, 68330, 68335, 68365, 68366, 68368, 69281, 69291 D) 68444, 65685 SN02053575 to SN10006093
Nexcare Opticlude Orthoptic Eye Patch
3M Canada Company
2009-05-25
2009-05-05 48185
Type III
900605, 902007, 902106
The insulin pump (numbers SN02053575 - SN10006093) may fail. This failure may present an intermittent or complete loss of function of the up and/or down buttons and in turn affect the desired pump operation. The primary boxes from these affected lots may not have the application instructions and caution statements printed on the inside flaps of the primary box, as otherwise indicated. When removing the waste bottle from the analyzer, waste material may leak both from the analyzer and from the waste bottle. This leakage is due to clogged vent holes creating over pressure in the bottle.
Waste Bottle For ABL7XX And 8XX Flex
Radiometer Medical APS
2009-05-25
2009-04-30 48225
Type II
D512 (905-590), D513 (905-802)
A) Symbia T/T2/T6/T16 B) Symbia S PSM with Validation Module
Siemens Medical Solutions USA, Inc. Molecular Imaging Group Roche Diagnostics Ltd
2009-05-25
2009-03-04 47070
Type III
2009-05-25
2009-04-30 47890
Type II
A) 08717733, 10275007, 10275008, 10275009, 10275010 B) 08717741 03009696001, 03265439001
For 905-590/D512 : WR-01, WR-02, WR-03, WS-01, WS-02, WS-03, WU-02, WU-03 For 905-802/D513 : WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU01, WU-02, WU-03, WU-04, WU-05, WU-06, WY-01 A) 1103, 1128, 1150, 1153, 1193, 1199, 1018, 1026, 1058, 1056, 1024, 1012 B) 1143, 1112, 1159 >10 Numbers, Contact Manufacturer
Possibility a patient injury can occur when the patient is lying on the patient bed and the automatic collimator changer is undergoing a collimator change operation even when the patient bed is retracted. Potential situation where the test validation ranges configured in the process systems managers (PSM) can incorrectly release a patient result where there are multiple reference ranges defined.
When all plans are loaded on the device, if the beam plan is edited, accessory information in the lantis can be potentially overwritten or removed, could result in mistreatment on another linear accelerator.
A) Artiste Syngo RT Therapist Assist B) Artiste Syngo RT Therapist A) Tilt/Elevating Seating System B) Tilt/Elevate/Recline Seating System Kinedx 4.2 SPF Reporting Workstation Orthos CM Bracket Syngo Dynamics Server Software
Siemens Medical Solutions USA, Inc. Oncology Care Systems Motion Concepts LP Siemens Medical Solutions USA, Inc. Ormco Corporation Siemens Medical Solutions USA, Inc.
2009-05-25 2009-05-25 2009-05-25 2009-05-25 2009-05-25
2009-04-21 48254 2009-02-19 46283 2009-02-05 46559 2009-02-13 46601 2009-03-04 47064
Type III Type II Type III Type III Type III
A) 08162807 B) 08162815 A) N/A B) N/A N/A 454-0210, 454-1210 100 90 480
A) 10024 B) 10040 A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer 92172-1 08H599H, 08H358H, 08J174J, 08J175J >10 Numbers, Contact Manufacturer
Syngo Imaging Update Package VB30A_HF26
Siemens AG
2009-05-25
2009-03-04 47067
Type III
10 014 063
1094, 01200
Pneumo Sure XL High Flow Insufflator 09-0142, Dean Scissors Roche/Hitachi Acetaminophen Assay Triathlon Offset Adaptor Trials
Stryker Endoscopy Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation Roche Diagnostics GMBH Howmedica Osteonics Corporation
2009-05-25 2009-05-25 2009-05-25 2009-05-25
2009-01-08 45983 2009-04-02 47701 2009-05-01 48042 2009-04-22 48074
Type II Type II Type III Type III
620-040-600, 620-040-610 09-0142 3255379190 5570-T-020, 5570-T-040, 5570-T-060, 5570-T-080 A) 00-5964-014-51, 00-5964-017-51 B) 00599601451 6939-0-430 06F16-10 A) N/A B) N/A C) N/A 801763 802100 87000
0804CE394 to 0810CE295 >10 Numbers, Contact Manufacturer All Lot Numbers N/A
Possibility of stress related cracks occurring in our power elevating seat actuator models as the result of atypical or extreme usage of the wheelchair seating system. Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected. Orthos CM Brackets are incorrectly labelled +9 degrees, but they have a torque of -9. Attachment will result in significant delay in treatment. There is potential issue in the Syngo Dynamics 5.1 reporting system. Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected. Due to several root causes leading to missing or mislinked Performed Procedure Step's some or all studies of a patient may become inaccessible from Syngo studio. With a 3rd party RIS, sometimes "study merge" does not work. Insufflators are powering off during surgery or not powering up completely. The 09-0142, Dean Scissors are breaking when used. The claim for significant bilirubin interference decreases from 28 mg/dl (478.8 mol/l) to 20 mg/dl (342 mol/l) icterus index for the Roche/Hitachi acetaminophen assay. Advisory reiterating to customers the potential for the adaptor trial to seize, the preventive maintenance measures, and risk mitigation measures, as stated in the package insert. These items may possess a nonconforming finish on the polished surfaces which could potentially increase wear and decrease the product life cycle on the articulated surface. A size 43mm Austin Moore endoprosthesis curved stem was found packaged as a size 45mm stem. The rechargeable battery pack can overheat with or without the presence of smoke causing the Martel printer to overheat in the i-STAT 1 analyzer system. In rare cases the trigger wire can become damaged and then compressed between the stent and the top cap, making it difficult to remove.
A) Nexgen LPS B) Nexgen LPS-Flex Femoral Components Austin Moore Stems - Curved 43 mm i-STAT 1 Analyzer System-Instrument A) Zenith Renu AAA Converter B) Zenith Renu AAA Main Body C) Zenith AAA Main Body Bifurcated Stent Terumo Advanced Perfusion System 1 Advance Perfusion System 1 Galileo Echo Blood Bank Analyzer
Zimmer Inc. Howmedica Osteonics - Stryker Ireland Abbott Point Of Care Inc. Cook, Inc.
2009-05-25 2009-05-25 2009-05-25 2009-05-25
2009-04-23 48206 2009-04-27 48207 2009-04-27 48245 2009-03-16 47349
Type II Type II Type II Type II
A) 61219714, 61204820 B) 61207901 LOIINRA >100 Numbers, Contact Manufacturer
Terumo Cardiovascular Systems Corp. Terumo Cardiovascular Systems Corp. Immucor Inc.
2009-06-08 2009-06-08 2009-06-08
2009-01-12 46050 2009-01-29 46444 2009-04-27 48195
Folate III Reagent Kit TransFx Drill Bit
Roche Diagnostics GMBH Zimmer Inc.
2009-06-08 2009-06-08
2009-05-08 48241 2009-05-06 48337
Type III Type II
4476433190 00-4450-054-00, 00-4450-056-00, 00-4450-058-00, 00-4450-063-00
A) All Lots B) All Lots C) All Lots 0013, 0017, 0020, 0021, 0144, 0193, 0396, 0601 Screws in the power manager board may come loose and come into contact with system 1 chassis. 31, 39, 55, 93, 219, 220, 263, 279, 584 Poor or intermittent connections. A non functioning CCM could potentially cause the user to operate pumps using local pump controls. Improvements of Echo software since the 1.1.2.28.1, to address the recalls previously N/A initiated: duplicate alphabetical sample barcodes, information for instruments interfaced to laboratory information system. 15068201, 15127201 Certain lots of the Folate III Reagent Kit may induce an elevated recovery of folate in liheparin plasma. 56454683, 70196100, 70185600, 70221300, Device possesses non-conforming tip geometry, reducing the efficiency of drilling action, 56454692, 70193000, requiring more force and potentially heating the bone surface during operation. 70205400
A) Pumps/Sequential Circulators B) BioComfort Arm Garments C) BioComfort Leg Garments
Bio Compression Systems
2009-06-08
2009-05-11 48425
Type III
A) SC-2004, SC-3004, SC-3008 B) GS-3035-M, GS-3035-S C) GS-3045-H, GS-3045-L, GS-3045-M, GS-3045-S N/A 96-210-10001 8098027
A) N/A B) N/A C) N/A
Medical devices sold in Canada by Bio Compression Systems are not licenced in accordance with the medical devices regulations.
XIO Radiation Treatment Planning System TM-400 Broach Handle Definition AS
Computerized Medical Systems Zimmer Trabecular Metal Technology, Inc. Siemens AG
2009-06-08 2009-06-08 2009-06-08
2009-05-05 48447 2009-05-08 48453 2009-02-25 48470
Versions 4.3.0 to 4.40.0 All Lots 64238, 64032, 64049, 64052, 64069, 64137, 64141, 64233, 64306, 64316, 64362 894213H S/N'S 96090GE6, 96091GE4, 98606GE7, 98607GE5, 98608GE3 A) N/A B) N/A
When beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. Device may fracture at the threaded tip during use, leaving the broach or trial in the surgical site. This update instruction provides improved fixation of the telescope support.
Custom-Pak Opthalmic Surgery Pak AW Volumeshare2 - Software Options A) Precicontrol Cardiac B) Precicontrol Cardiac II A) Vacora Vacuum Biopsy System B) Vacora Vacuum Biopsy System - Cannula
Alcon Laboratories Inc. GE Healthcare Roche Diagnostics GMBH
2009-06-08 2009-06-08 2009-06-08
2009-05-01 48472 2009-04-21 45984 2009-03-26 47413
13305-01 B79011MA A) 03530477190 B) 04917049190 A) VC10118P B) VC10118MR
Identification of oxidization on some of the 25GA Trocar Blades packaged in the 25GA Total Plus paks which are part of the Alcon custom-pak procedure pack. Under certain conditions, the series could be incorrectly labelled in image view, which could lead to under-treatment of a tumour. Potential for precision issue with the Elecsys Cardiac and Cardiac II. Specifications for the intra-assay precision was not met independent of the Elecsys Digoxin Reagent or Precicontrol lot used.
Some Vacora 10g plastic coaxial cannulas may leave a small metal filament in the breast.
Bard Peripheral Vascular, Inc.
2009-06-08
2009-04-14 47925
Type II
Lifepak 9/9P Internal Paddles & Handles
Physio-Control, Inc.
2009-06-08
2009-02-17 48161
Type II
A) HUSA1668, HUSC1533, HUSD1075, HUSI1063, HUSG0594 B) HUSH0816, HUSI0216, HUSC1588, HUSD2647 11130-0000XX, 11131-0000XX, 800441- > 10, Contact Manufacturer XX, 802154-XX A) 48284050 B) 48284051 B03-4585-54 A) All Lot Numbers B) All Lot Numbers TP93037
A) MANTIS Rod Inserter B) MANTIS Rod Inserter Inner Shaft Advia 70 Testpoint Haemotology High Con
Stryker Spine SAS
2009-06-08
2009-04-28 48210
Type II
2009-06-08
2009-05-12 48471
Type III
Acist Angiographic System-Manifold Kit
Acist Medical Systems Inc.
2009-06-08
2009-05-13 48480
Type II
BT2000
3168H
Insufflation Tubing With Filter SmartMonitor 2 Infant Apnea Monitor Updated recall # 48114 previously posted on 200905-11. Preciset TDM I / Preciset TDM II Vertier Table Headrest Attachment Cypher Select + Sirolimus-Eluting Stent
Medovations Inc. Respironics Inc.
2009-06-08 2009-06-08
2009-05-14 48488 2009-04-27 48114
Type II Type I
SU1101 4002, 4003
209296 S/N: 3000033364 to 3000038740
Roche Diagnostics GMBH Stryker Communications Cordis Europa N.V.
2009-06-08 2009-06-08 2009-06-08
2009-05-12 48228 2009-05-15 48498 2009-05-08 48561
Type III Type II Type III
03375781190, 03375790190 0788-300-012 CRB08225, CRB08250, CRB08275, CRB08300, CRB08350, CRB13225, CRB13250, CRB13275, CRB13300, CRB13350, CRB18225, CRB18250, CRB18275, CRB18300, CRB18350, CRB23225, CRB23250, CRB23275, CRB23300, CRB23350, CRB28225, CRB28250, CRB28275, CRB28300, CRB28350, CRB33225, CRB33250, CRB33275, CRB33300, CRB33350 N/A
15617400 & 15612200, 15612300 All Lot Numbers >100 Lots, Contact Manufacturer
Sterilization efficacy for the current labelled methods cannot be confirmed. These Lifepak 9/9P internal defibrillation handles without discharge control & custom-mated paddles, were discontinued in August 2008. The stainless steel split sphere in the Mantis Rod Inserter Shaft has the potential to become deformed when subjected to high force. Once deformed, the split sphere may separate from the shaft. Complaints that the Percent Eosinophils (EOS) is not recovering within the range specified for lot TP93037 of testpoint high control. The supplier confirmed a value assignment error for this lot. The manufacturer has received field reports of a bulge and leaks on the side of the 2.5" highpressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the product. The device, model SU1101, is not licensed for sale in Canada. It is however the same product in specifications and materials as JA-1101, which is licensed for sale in Canada. A variation in the monitor manufacturing process could expose wires to potential short circuit of the wire leading to the alarm module. This can result in a situation where the alarm will not sound. Bottle caps are being too difficult to remove. The headrest has two pinch points that could result in hospital staff injury during the transportation of the headrest when it is detached from the table. In response to an increased number of complaints of cracks in the balloon inflation port hub of this coronary stent, a field safety notice has been issued to remind users to follow inspection and preparation steps.
Human STFR Quantikine IVD Kit
R & D Systems, Inc.
2009-06-08
2009-03-03 48601
Type II
259416, 261514, 262759
Quantikine IVD Human B2-Microglobulin
R & D Systems, Inc.
2009-06-08
2009-03-04 48674
Type II
N/A
260980
Ready Kit A) Sigma Pacemaker System B) Kappa 600 KDR Series Pacemakers C) Kappa 700 KDR Series Pacemakers D) Kappa 700 KD Series Pacemakers E) Kappa 700 KSR Series Pacemakers F) Kappa 900 KSR Series Pacemakers
Cardiac Science Corporation Medtronic Inc.
2009-06-08 2009-06-08
2009-02-10 48618 2009-05-18 48540
Type III Type I
N/A A) SD203, SD303, SDR203, SDR303, SDR306, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVDD303, SVVI103 B) KDR603 C) KDR703, KDR706, KDR721 D) KD701, KD703, KD706 E) KSR701, KSR703, KSR706 F) KSR903 SD203, SD303, SDR203, SDR303, SDR306, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVDD303, SVVI103
N/A A) >100 Lots, Contact Manufacturer B) PHH620224S, PHH620227S C) PGY623319S, PGY623323S, PGY623355S, PGW621053S, PGR625317S, PGR625959S D) >10 Lots, Contact Manufacturer E) >1000 Lots, Contact Manufacturer F) >100 Lots, Contact Manufacturer
During manufacturing, it was found the standard used to calibrate the assay, may have evaporated in some vials. If evaporation occurs this will cause the standards to read erroneously. During manufacturing, it was found the standard used to calibrate the assay, may have evaporated in some vials. If evaporation occurs this will cause the standards to read erroneously. Ready kits, part# 5550-003, contain gloves and antiseptic wipes that are not licensed in accordance with the medical devices regulations. The pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components (e.g. battery, connector). This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
Sigma Pacemaker System
Medtronic Inc.
2009-06-08
2009-05-18 48702
Type I
>1000 Lots, Contact Manufacturer
This is an update of performance and patient management recommendations for a subset of Sigma pacemakers previously recalled because of an increased rate of failure associated with interconnect wire separation caused by a particular cleaning solvent used in manufacturing.
A) Multidiagnost Eleva-Flat Detector B) Allura XPER FD10/10-Main Unit Architect Reaction Vessel Chemiluminescent Substrate
Philips Medical Systems Nederland B.V. Abbott Laboratories Diagnostic Division Siemens Healthcare Diagnostics Inc.
2009-06-22 2009-06-22 2009-06-22
2009-05-15 48595 2009-05-19 48605 2009-05-06 48608
A) 70834 B) ALLURA XPER FD10/10 7C15-01 L2SUBX
A) N/A B) N/A > 10 Numbers, Contact Manufactuer 253, 254
A) Vitros 3600 Immunodiagnostic Software B) Vitros 5600 Integrated System Software
Ortho-Clinical Diagnostics Inc.
2009-06-22
2009-05-28 48864
Type II
A) 680 2865 B) 680 2863
A) 36000116, 36000130 B) 56000193, 56000298, 56000124, 56000136, 56000336, 56000337
Prelude Short Sheath Introducer
Merit Medical Systems Inc.
2009-06-22
2009-04-20 48882
Type II
VS Ventilator A) Wiseguide Guide Catheter Femoral B) Wiseguide Guide Catheter Allright C) Wiseguide Guide Catheter Voda D) Wiseguide Guide Catheter Amplatz E) Wiseguide Guide Catheter Bypass F) Wiseguide Guide Catheter Multipurpose G) Wiseguide Guide Catheter Radial H) Wiseguide Guide Catheter Kimny
Resmed Paris Medi-Tech Boston Scientific Corporation
2009-06-22 2009-06-22
2009-06-01 48885 2009-03-13 47359
Type III Type III
PSS-5F-4-018MT, PSS-5F-4-038MT, N/A PSS-5F-4MT, PSS-6F-4-018MT, PSS-6F4MT, PSS-7F-4MT, PSS-8F-4MT VSU0802002, VSU0802003, VSU0802001, N/A VSU0711510 A) 16320-02, 19500-02, 19500-29, 19815- A) H74916320021, H74919500020, H74919500290, H74919815920 92, H74919815520 B) H749198155010 B) 19815-501 C) 16320-72, 16320-78, 19500-71, 19500- C) H74916320721, H74916320781, H74919500710, H74919500720, H74919500730, 72, 19500-73, 19500-74, 19500-77, H74919500740, H74919500770, H74919500780, 19500-78, 19815-71, 19815-72, 19815H74919815710, H74919815720, H74919815730, 73, 19815-74 D) 16320-17, 16320-18, 16320-20, 16320- H74919815740 D) H74916320171, H74916320181, 21, 19500-20, 19500-21, 19500-22 H74916320201, H74916320211, H74919500210, E) 19815-446 H74919500220, F) 16320-141, 19500-39, 19815-41 E) H749198154460 G) 19815-554 F) H749163201411, H74919500390, H) 19815-583 H74919815410 G) H749198155540 H) H749198155830 960005 2843263, 2869123, 2845534, 2845530, 2844799, 2952392, 2852394, 2842528, 2844381, 2843270, 2843268 20148707, 20148714, 20153849, 20153865, 20154971 AC001 TO AC0221
The system may shut down and not restart due to a manufacturing error in the printed circuit board in the main-cabinet. Reaction vessels made from specific lots of resin had an increased likelihood of producing error code 1006 and error code 1007 and incorrect/elevated results. Complaints received regarding substrate l2subx lots 253 and 254, which may affect the performance of the Immulite 2000 and Immulite 2500 assays. These substrate lots may introduce a shift in both quality control and patient results. Complaint received of a biassed glucose result on a Vitros 5600 Integrated System. Investigation has found that under a very specific set of circumstances, when the display/report screen is configured by the operator, an erroneous result could also be generated by the Vitros 3600 Immunodiagnostic System. The sidearm tubing may detach from the sheath during use. If this failure occurs, it may result in excessive patient blood loss and/or risk of blood-borne pathogen exposure to those in the surrounding area. Resmed received a report of a failure of a VS Ventilator in Japan that had resulted in a failure of ventilation at start-up. It occurred within a hospital environment. Difficulties in connecting the product hubs with the Y-adaptors and toughy borst connectors. Product out of specs with thread outer diameters.
PFC Sigma CR Non-Porous Left Femoral
Depuy Orthpaedics, Inc.
2009-06-22
2009-05-29 48935
Type II
Disposable Endoscopic Surgery Blades Steris CMAX Surgical Table Hand Control
Smith & Nephew, Inc., Endoscopy Division Steris Corporation
2009-06-22 2009-06-22
2009-05-08 48408 2009-05-22 48912
Type II Type III
7206010, 7206011, 7210499 N/A
A) Picis OR Manager B) Picis Preop Manager C) Picis Anesthesia Manager D) Picis PACU Manager E) Picis Critical Care Manager Instrument Manager
Picis Inc.
2009-06-22
2009-04-08 48937
Type II
Data Innovations
2009-06-22
2009-05-11 48997
Type II
BD Falcon 100X20 mm Tissue Culture Washer Disinfectors With Transformer ASC 2000 Ambulatory Surgical Table
Becton, Dickinson And Company Getinge Disinfection AB Mediland Enterprise Corporation
2009-06-22 2009-06-22 2009-06-22
2009-02-17 47220 2009-04-24 48035 2009-04-17 48613
A) model/catalog # 4235 B) model/catalog # 4250 C) model/catalog # 4220 D) model/catalog # 4245 E) model/catalog # 1110 IM-B02V8.06, IM-B02V8.07, IMB02V8.08, IM-B02V8.09 N/A 9027, 9100 MTS110003
A) N/A B) N/A C) N/A D) N/A E) N/A N/A
A small number of PFC Sigma Cruciate Retaining Non-Porous size 5 left femoral cemented components within the affected lots have been identified as having a microscopic crack on the lateral side of the condyle in the posterior chamfer region. Microscopic cracks have the potential to affect the performance of the implant. There is the potential for a compromised sterile barrier in the tyvek lid of the primary packaging. A limited quantity of the CMAX Hand Controls were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. It is possible that screws without the loctite can work loose and the clip can become separated from the hand control. If both screws back out completely, the internal components of the hand control and/or the table control board may become damaged. This could cause a loss of hand functionality. If not properly configured, software will allow patient allergy and precaution data to be overwritten with automatic updates from the hospital information system (HIS). This can result in deletion of allergy information.
The previous results retrieved from the specimen management database, which may be used by rules, may not be the most recent previous version.
Dishes containing a small crack, which may result in the leakage of cell culture media during incubation. This crack is located on the bottom of the dish along the stacking ring.
> 10 Numbers, Contact Manufactuer > 10 Numbers, Contact Manufactuer 07160407V3.01, 043600401V200, 043600402V200, 041600323V200, 045100705V300, 061400907V3.00, 061406905V300 > 10 Numbers, Contact Manufactuer > 10 Numbers, Contact Manufactuer
The frame earth of the supply transformers for the Getinge 9100-series Washer Disinfector have burnt out on one installation in Australia. Repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hosing causing loss of control of the table surface.
Dyonics 25 Tube Set Kits Compax 40E Table
Smith & Nephew, Inc., Endoscopy Division GE Healthcare
2009-06-22 2009-06-22
2009-05-29 48968 2009-02-18 45258
Type II Type II
7211005, 7211006 N/A
ZMR Hip System-Stems 2.7mm Cortical Screw Self-Tapping Alumina Ceramic Femoral Head
Zimmer Inc. Zimmer Inc. Zimmer Inc.
2009-06-22 2009-06-22 2009-06-22
2009-05-27 48913 2009-06-01 48914 2009-06-01 48988
00-9982-015-18 00-4827-024-01 00-6428-032-02
60698102 60886890 61007046
The material thickness of the trays used for packaging the tube sets may not be sufficient to maintain the sterile barrier. Table locks may not actuate, causing tabletop to unexpectedly float in either of the following axes: 1) lateral axes, 2) bidirectional (longitudinal and lateral) axes, which could injure patient or user. The stem threads on some units in this lot may be nonconforming, preventing the compression nut from engaging on the stem. The 2.7mm Cortical Screw Self-Tapping package could potentially hold the 4.0mm cancellous screw partially threaded (part number 00-4840-022-01). Some units in this lot may have the inner tyvek peel tab trapped within the outer seal. This configuration could result in delamination of the inner tyvek seal as the package is opened, complicating removal of the implant from the package while maintaining sterility.
A) Integris V5000/BV5000 B) Integris H5000F Cardiology Imaging System C) Integris H5000C Cardiology Imaging System D) Integris BH5000 Cardiology Imaging System E) Integris Allura F) Allura XPER FD10 G) Integris H1000 H) Integris H3000 I) Integris V3000 Carescape V100 Muse Cardiology Information System
2009-06-22
2009-05-12 49048
Type II
GE Medical Systems Information Technologies GE Healthcare
2009-06-22 2009-06-22
2009-02-09 46236 2009-03-04 46833
Type II Type II
A) 722041*, 722042* B) 722017 C) 722016 D) 722021 E) 722043*, 722044* F) ALLURA XPER FD10 G) N/A H) N/A I) N/A V100-QBAA-CXAA-XX MUSESW7-XXXXXXXX
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A > 10 Numbers, Contact Manufactuer > 10 Numbers, Contact Manufactuer
A partial grid switch failure may occur in Allura XPER and Integris systems that may result in a higher x-ray dose than expected. This issue may pose a risk for patients or users. The potential failure can lead to a radiation exposure rate in excess of the 11.5 R/min Health Canada requirement. However, it will only occur if the grid switch fails during fluoroscopy examinations using high KV values.
CIC Pro Clinical Information Center
GE Healthcare
2009-06-22
2009-02-19 46853
Type II
CIC-XXXX-XXXXX-XXXXX*
S/N'S SDY09020430GA & SDY09030443GA
Hinged Knee Brace Intellivue MP70 Patient Monitor System
Trainer's Choice Philips Medizin Systeme Boeblingen GMBH
2009-06-22 2009-06-22
2009-01-07 48389 2009-05-22 48839
Type III Type II
101 M8007A
8-31313-00003-2, 8-31313-00004-9, 8-3131300002-5 N/A
Sireskop SX/SD
Siemens AG
2009-06-22
2009-02-11 47071
Type III
10093754, 31 11 676, 3111668
21005, 21040, 21087, 21107, 21110, 31036, 34170, 36103, 41021 > 10 Numbers, Contact Manufactuer 235018, 235036, S27947, S27957 7839010, 7910010
1.5T Signa Infinity MR Excite - System Posey Buckle Erytype S RH Donor Plates
GE Healthcare J T Posey Co. Biotest Medical Diagnostics GMBH
2009-06-22 2009-06-22 2009-06-22
2009-05-11 47837 2009-05-29 48899 2009-04-03 49138
Type II Type III Type III
2294302, M3000CB N/A 806190100
Aria Radiation Oncology
2009-06-22
2009-05-08 49074
Type II
8.1.15, 8.5.11, 8.6.07, HIT
> 10 Numbers, Contact Manufactuer
The alarm and pulse volume indicators are inverted on the label of french language units. Stored and printed records may contain incorrect information when records containing default patient identifiers (PID) are confirmed as valid PID's in Muse Cardiology Information Systems versions 7.0, 7.01, 7.0.2, 7.1 & 7.1.1 Circuit board supplied by 3rd party for MP 100 hardware platform for CIC Pro version 5.1 software may fail and result in potential loss of monitoring and inability to power up after powering down of CIC Pro. Evidence of mold was found on the leather pieces on the outside of the braces. Product integrity and effectiveness was not affected. If scheduled orders are documented and edited prior to the orders' original schedule time, Carevue Chart Release C.0 (running on the DC7100 computers of the Intellivue MP700 patient monitor system) can create a second instance of the same order marked as pending, if the following conditions occur: 1. An order or intervention is entered as a scheduled administration and 2. A clinician charts the pending order earlier than scheduled and 3. A user/clinician changes, edits or acknowledges the A defective behaviour in data transport layer of the network file system (NFS) connection could cause series as marked successfully archived even though the content is saved sporadically with defective pixel or header data. An error in the coding of the 11.1_M4_0818A version of software can result in images being flipped under very limited and specific conditions. Product made with incorrect buckle, potential for failure. One lot of Erytype S RH Donor Plates contains an error in the labelling on the foil packet. The product is correctly identified, however the product description immediately below is incorrectly stated. The outer box information is correct as well as the barcode information on the plate frames and microplate strips. Software anomaly leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result, potentially leading to serious injury. The affected MR accessory carts may contain magnetic material and can therefore be attracted to the magnet. This problem affects revision C and D of the software. In rare circumstances, the settings for paper scale type and recorder speed may revert back to the factory default settings, which are: USA paper style and 3 cm/min paper speed. This behaviour would have the most impact in Europe and Asia/Pacific where other settings are preferred. If this change remains undetected by the user, it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. The problem occurs when the powerup/boot sequence of the fetal monitor is interrupted, e.g. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption. 1. When images are saved or filmed that contain the curved multi_planar reformation section (CMPRS) while using the dental application v4.0.0 to v4.0.1.9999 on the extended brilliance workspace, the right/left annotations will be reversed on views that were created with a short curve. An Arena instrument set to deliver 50 ml/min. may deliver between 40 & 60 ml/min., contrary to operator and service manuals. Sys1000 manuals do not specify blood flow accuracy as required by IEC standard.
A) Achieva 3.0T MRI System-Main Unit B) Achieva 1.5T MRI System-Main Unit A) Avalon Fetal Monitor FM30-Main Unit B) Avalon Fetal Monitor FM20-Main Unit
Philips Medical Systems Nederland B.V. Philips Medizin Systeme Boeblingen GMBH
2009-06-22 2009-06-22
2009-06-09 49149 2009-06-09 49150
Type II Type II
A) ACHIEVA 3.0T B) ACHIEVA 1.5T A) M2703A B) M2702A
A) N/A B) N/A A) DE53001002 Through DE53107383 B) DE53001002 Through DE53107383
Brilliance 6/10/16 Slice CT-SFRTWR Dent
2009-06-22
2009-06-10 49151
Type II
455011202691
N/A
A) System 1000 Dialsate Delivery System - Aurora B) System 1000 Dialsate Delivery System - Tina C) Arena SPP Hemodialysis Delivery System D) Arena SPX Hemodialysis Delivery System
Baxter Healthcare Corporation
2009-07-06
2009-04-09 47924
Type III
A) Isolex 300I Magnetic Cell Separator B) Isolex 300 Magnetic Cell Separator Stat G3+ Cartridges
2009-07-06
2009-05-04 48344
Type II
A) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PHA B) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PH, SYS1000-L3PHA, SYS1000-L3PHDP C) ARENASPP-DH, ARENASPP-H D) ARENASPX-BDH, ARENASPX-HR A) 4R9734 B) 4R9734 06F03-01, 06F03-02
A) All Lots B) All Lots C) All Lots D) All Lots
A) All Lots B) All Lots P08321C
HSA used to produce this reagent does not comply with the USP monograph as per what the current labelling and package inserts state. It complies with European pharmacopeia instead. Box numbers 1491 and 1534 of this device from lot # P083221C have suboptimal pouch seals. If a cartridge or suboptimal pouch seal is run, there is a possibility that the performance of the cartridge assays may be impacted. The LCT-1000 Deep Tissue Laser Therapy is an unlicenced medical device. Manufacturer has determined that specific lots have shown decreased specificity for negative populations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus.
Abbott Point Of Care Inc.
2009-07-06
2009-05-12 48497
Type II
LCT-1000 Therapy Laser A) Advia Centaur B) Advia Centaur XP
Litecure, LLC Siemens Healthcare Diagnostics Inc.
2009-07-06 2009-07-06
2009-05-15 49192 2009-06-10 49196
Type II Type III
N/A A) 07566733 B) 07566733
N/A A) > 10, Contact Manufacturer B) > 10, Contact Manufacturer
Definium 5000 Digital Radiographic System
GE Healthcare
2009-07-06
2009-06-11 47773
Type II
5220493-2
GEHC00070 & GEHC00096
Chloride Membrane on ABL 700 & 800 Flex
Radiometer Medical APS
2009-07-06
2009-06-05 48585
Type III
942-061
177
Delfia Xpress PAPP-A Kit Sur-Catch No Tip Nitinol Stone Basket
Wallac OY Gyrus Acmi, Inc.
2009-07-06 2009-07-06
2009-05-21 48607 2009-06-04 49030
Type II Type II
6003-0020 5711222
490042, 490656, 503140, 506860, 507311, 516518 89261CB, 89262CB, 91665DB, 91666DB
A) Nexgen Rotating Hinge Knee-Femoral Component B) Nexgen Rotating Hinge Knee-Tibial Component
Zimmer Inc.
2009-07-06
2009-06-08 49105
Type II
A) Immunocap 250 Specific IGE Control B) Immunocap 100 Specific IGE Control
Phadia AB
2009-07-06
2009-03-29 49233
Type III
A) 00-5880-014-01, 00-5880-014-02, 005880-015-01, 00-5880-015-02, 00-5880016-01 B) 00-5880-002-00, 00-5880-004-00, 005880-005-00, 00-5880-006-00 A) 10-9449-01 B) 10-9449-01
A) 60147327, 60230599, 60137094, 60163665, 60173203, 60144695, 60174823, 60186251, 60141825 B) 60195329, 60160461, 60203906, 60206499, 60180540, 60170823, 60191094 A) BNMAX, BNMAY, BNMAZ B) BNMAX, BNMAY, BNMAZ
When configured for AEC, after first exposure terminates, subsequent exposures fail to terminate because functionality of ion chamber ramp comparator with low reference voltage is not reliable. Composition of electrolyte solution in membrane units for the affected lot 177 are incorrect and cause the sensitivity of chloride electrode to be very low and the analyzer rejects calibration. There is a decrease in the measurement of PAPP-A levels compared to previous lots, leading to the possibility of an increased false positive rate in screening programs. Due to an error, some product was shipped out with a new polyamide sleeve material before the qualifying process was completed. Because of this, Gyrus ACMI cannot ensure that the product's shelf life will meet the expiration date on the label. This action is being conducted because these components are labelled with a ten year expiry period when in fact these components expire five years after manufacture.
Phadia AB, (Sweden) voluntarily recallsImmunoCAP Specific IGE Control (art.no 10-949-01) containing vial lot BNMAX, BNMAY, or BNMAZ using ImmunoCAP Allergen E1. Manufacturer updates information on target range values for one of seven ranges stated in the directions for use. Product is a control sample used by laboratory for internal quality assurance. A new range is established for ImmunoCAP Allergen E1. For some customers the results may be out of range and could result in a quality assurance investigation at the customer's site.
Dual Offset Broach Handle Left and Right Impression Coping Closed Tray Regular Platform 05x9mm Flexicair
Biomet, Inc. Nobel Biocare AB
2009-07-06 2009-07-06
2009-03-31 48593 2009-05-21 48621
Type II Type II
N/A N/A
All Lots 687218
Handle body may crack or fracture, which could puncture or rupture the skin of the patient, surgeon or attending nurse and lead to increased risk of infection. Impression Coping Closed Tray NobelActive Internal Regular Platform (RP) 05x9mm (article no. 34235, lot no. 687218) was incorrectly packaged with the larger size 06x9mm. It is possible for the identified devices to emit smoke from the blower box assembly. Hazard of smoke inhalation and presence of smoke which can trigger smoke detection alarms. Use of the current available version of the 10ml diluent syringe, part number (p/n) 9212368 (without spacer), on a Cell-Dyn 1700, Cell-Dyn 1700cs, or Cell-Dyn 1800 with a die-cast syringe drive may result in diluent leakage during initialization of the analyzer, resulting in "diluent empty" faults. Received a report of damage to the distal shaft of the catheter. While the issue should be detected during the preparation of the product, it has the potential to cause a leak of contrast material. A leak has the potential to lead to a variety of catheter functional failures and clinical consequences as described in the instructions for use. Patients who have already been treated are not affected by this action and this action does not affect any other part number or lot number of the Powersail product line. Previous results retrieved from the specimen management database, which may be used by rules, may not be the most recent previous result. Customer complaints received regarding inaccurate results with Dimension Vista Bun Flex Reagent Cartridge in that test results may be falsely elevated or depressed, with a variable error magnitude. Potential risk of interference when using BrainLAB M3 on a Varian Linear Accelerator with the Internal Varian Multileaf Collimator not in Park mode during treatment. The Internal Varian F-Collimator could interfere with the intended conformal fields of the BrainLAB M3 during patient treatment. This may cause a critical under-dosage of the target region. The older version of the device has a design defect which allows for a fatigue related failure. There are two screws that attach the cage to the bracket which may fatigue over time and fail causing the cage to become detached from the mount and fall. In rare cases, the target image cannot be displayed or output to an external device after the system is simultaneously operated from the control room and the examination room in the Radrex-i system. OCD has received complaints from customers reporting that caps on several reagent red blood cell product vials are too tight. In some of those complaints, customers reported breaking or cracking of the glass reagent vial while attempting to unscrew the cap prior to use. Review of test records indicated that the two impacted TM55 Stress Treadmills may not have received adequate testing prior to being shipped from the factory. A small percentage of the devices (approximately 1%) may deliver less than the intended amount of ultrasound. This reduction in ultrasound output is the result of partial loosening of internal glued components within the small black cylindrical head, called a transducer. Reduced ultrasound output may affect the progress of patient fracture healing. There is potential for the Fowlers (backrests) to drift down to the flat position on the beds. The cause of the drifting Fowler is the Fowler clutch wrapspring having the potential to entangle in between the cup and coupler of the Fowler clutch assembly. During post-sterilization inspection of the outer blister of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. (Note: the inner blister seal was not affected).
Hill-Rom Manufacturing, Inc.
2009-07-06
2009-05-18 49146
Type II
I3000, M4000
N/A
A) Cell-Dyn 1700 Analyzer/1700CS Analyzer B) Cell-Dyn 1800 Analyzer
2009-07-06
2009-06-12 49223
Type III
A) 03H53-01, 03H57-01, 03H57-03 B) 07H77-01
A) N/A B) N/A
Powersail Coronary Dilation Catheter
Abbott Vascular
2009-07-06
2009-06-18 49279
Type II
1005726-08
7112051
Instrument Manager Dimension Vista System-Urea Nitrogen Assay
Data Innovations Siemens Healthcare Diagnostics Inc.
2009-07-06 2009-07-06
2009-06-18 49308 2009-06-19 49361
Type III Type III
IM-B02 VX.XX K1021
N/A 09061AA
M3 Micro-MLC For Varian With MLC
Brainlab AG
2009-07-06
2009-03-19 47235
Type II
41600-3, 41600-5, 41600-6
01-006-41600, 01-044-41600, 41600-052-99, E41600-3/30793
E-Cylinder Canister Holder
Stryker Communications
2009-07-20
2009-06-08 49172
Type II
0682-000-449, 0682-001-111
All Lots
Digital Radiography Imaging System
Toshiba Medical Systems Corporation
2009-07-20
2009-06-12 49202
Type II
TFD-3000A1/WV
N/A
A) 0.8% Resolve Panel A Reagent RBC B) 0.8% Resolve Panel B Reagent RBC C) 0.8% Resolve Panel C Reagent RBC
Ortho-Clinical Diagnostics Inc.
2009-07-20
2009-06-11 49448
Type III
A) 6902317 B) 6902318 C) 6902319
Quinton QStress TM55 Stress Treadmill Exogen Bone Healing System
Cardiac Science Corporation Smith & Nephew, Inc.
2009-07-20 2009-07-20
2009-03-30 49032 2009-06-10 49177
Type II Type II
N/A 71034101
A) VRA124, VRA125, VRA126, VRA127, VRA128 B) VRB123, VRB124, VRB125, VRB126, VRB127 C) VRC123, VRC125, VRC126, VRC127 Serial # 11040079567, 11040079568 > 10 Numbers, Contact Manufacturer
A) S3 Med/Surg Bed Fowler B) Secure II Med/Surg Bed Fowler Dall Miles Trochanter Cable Grip System
Stryker Medical
2009-07-20
2009-06-11 49199
Type II
A) 302S3-000-000 B) 3002-000-000 6704-0-210
A) All lots B) All lots Serial # 29233201
2009-07-20
2009-06-15 49278
Type II
Olympus Mobile Workstation, Transformer
Keymed (Medical & Industrial Equipment) Ltd.
2009-07-20
2009-06-16 49339
Type III
MAJ-174, MH-787
Serial Numbers Less Than 2810808
Carendo Multipurpose Hygiene Chair
Arjo Hospital Equipment AB
2009-07-20
2009-06-16 49446
Type II
BIB2003-01
BD MultiSET Software V.3.0.1
Becton, Dickinson And Company
2009-07-20
2009-06-24 49459
Type III
643347, 643437, 644459
N/A
The fuse holder on the transformers assembled on the bottom of a number of Olympus WM Series Mobile Workstations (WM-NP1, WM-WP1, WM-DP1, WM-SC) can overheat and arc if the fuse carrier is not sufficiently tightened. A limited number of complaints have been received regarding the Carendo related to skin pinching. If the Carendo is not used in compliance with the device instructions for use. Trending has shown a number of events relating to what has been generally described as clip detachments. A multi-sipping issue was found in BD MultiSET Software Version 3.0.1. The software is not adjusting its acquisition criteria for some samples. It only displays the last batch of events acquired.
Smith & Nephew has received complaints of lugs missing from the femorals. The missing lugs are apparent to the user upon opening of the inner sterile tray.
Genesis II Femorals Coonrad/Morrey Total Elbow System Laparo-Thoraco Telescopes, Cable Unit
Smith & Nephew, Inc. Zimmer Inc. Olympus Winter & IBE GMBH
2009-07-20 2009-07-20 2009-07-20
2009-06-10 49201 2009-06-09 49362 2009-06-25 49518
71420026
08HM17084
32-8105-038-00 61249897, 61249899 A50001A, A50003A, A50021A, A50023A, > 10 Numbers, Contact Manufacturer WA50003L
Some units in these lots may contain a void in the side seals of the Tyvek/poly pouch. Due to a geometrical incompatibility between the light guide cable and light source the "high intensity mode" cannot be switched on. Due to a production failure of the manufacturing partner, the distance between the coverglass of the light guide cable and the ledge does not meet specifications. Production between January 2009 and May 28, 2009 was affected.
Architect I System-Total B-HCG Reagent
Abbott Ireland Diagnostics Division
2009-07-20
2009-06-30 49556
Type III
7K78-20, 7K78-25
BHR Acetabular Cups
Smith & Nephew Orthopaedics Ltd.
2009-07-20
2009-06-30 49557
Type II
74120152
74908JN00, EXP 17 DEC. 2009, 74908JN01, EXPAbbott has observed an increase in complaints for the following error codes when using ARCHITECT Total -hCG Reagent with specified lots: -1109 "assay (X) number (Y) calibration failure, ratio too small for CAL B/CAL A" and /or - 1005 "result cannot be calculated, final RLU read is outside the specification of the lowest calibrator". (L)08CW16248 The engraving on the plastic cap does not match the outer label indications for size. The BHR Acetabular Cup and femoral head packages include labelling and colour coding to prevent mismatch in component size selection. The engraved numbers on the impactor cap do not agree with this information and are erroneous. As such, the numbers engraved on the impactor cap could cause some confusion during surgery and lead to surgical delay. N/A The Trident Acetabular System surgical protocol (LSP55) needs to be modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique. Advanced Bionics (AB) is notifying implant surgeons about the removable magnet component of the HiRes 90K Cochlear Implant (model no. CI-1400-01 and CI-1400-02h). The magnet is designed to be surgically removable if the Cochlear Implant patient needs to undergo an MRI. AB reports that devices manufactured between May 27 and June 30 of 2005 may have a magnet laser welding defect. The magnets were made such that the metal case surrounding the magnet is not properly welded. A patient implanted with an unwelded magnet could experience a decrease in the strength of the magnet over time, leading to headpiece retention issues. AB is aware of 14 defective magnets. In 7 cases the unwelded magnet resulted in surgery and replacement of the magnet. 2 of the replacements were for devices sold in Canada. An additional 5 potential cases outside of Canada and the USA are under investigation. Based on random sampling AB has determined the weld failure occurred at a rate of 1 in 126 devices. Devices manufactured outside the above time frame were not affected. While running the AmpliLink software, there are possibilities (under certain circumstances) that an assay is being performed with the test file parameters of another assay.
Trident Acetabular Surgical Protocol
2009-07-20
2009-06-15 49269
Type II
N/A
Removable Magnet Hires 90K
Advanced Bionics, LLC
2009-07-20
2009-06-12 49409
Type II
CI 1400-01, CI-1400-01, CI-1400-02H
N/A
A) Amplilink Software V 3.1.1 B) Amplilink Software V 3.1.2 Build 0502 C) Amplilink Software V 3.2 D) Amplilink Software V 3.2.1 E) Amplilink Software V 3.2.2 Centricity PACS Workstation - Hardware
Roche Diagnostics Ltd.
2009-07-20
2009-06-16 48878
Type II
2009-08-03
2009-05-26 47838
Type II
A) CAT #04807197001 B) CAT #04855094001 C) CAT# 04862392001 D) CAT #05093236001 E) CAT# 05201357001 K2033LP
A) All Lots B) All Lots C) All Lots D) All Lots E) All Lots > 100 Numbers, Contact Manufacturer
A) Central Venous Catheterization Set B) Central Venous Catheter Accu-Chek Softclix Lancets Kuschall K-Junior Manual Wheelchair Stromatolyser-IM NX 8000 With V. NX2008 Or NX.x.8000
Arrow International, Inc.
2009-08-03
2009-05-11 48476
Type II
A) CS-12123-E, CS-15123-E B) MC-12123, MC-15123 03146693119, 03146707119, 03583031002 K-Junior SIM-220A NX SOFTWARE 2.0.7000, NX SOFTWARE 2.0.8000, NX SOFTWARE 3.0.7000, NX SOFTWARE 3.0.8000 N/A 10041762
A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer > 10 Numbers, Contact Manufacturer 806135534 c0910, c9011, c9013, c9014, c9015, c9016, c9017 N/A
Roche Diagnostics GMBH Kuschall AG Sysmex Reagents America AGFA Healthcare N.V.
2009-08-03 2009-08-03 2009-08-03 2009-08-03
2009-06-01 48484 2009-06-15 49293 2009-06-26 49463 2009-06-22 49490
Type III Type II Type III Type II
Default configuration may have been modified so that rejected images are included in the retrieved exam, resulting in those images being displayed erroneously on external DICOM device. The catheters have a deformity in the lumen at the catheter juncture hub which can cause difficulty in passing the spring wire guide through the hub of the catheter or removing the spring wire guide from the catheter. There is a potential that a single lancet may miss the protective cap in the Accu-Chek Softclix Lancet boxes and in the bags in blood glucose meter kits. A breakage of the pushbuggy handle has been occurring at a calculated weight of 65 kg. Seven lots of Stromatolyser-IM (SIM-220A) manufactured between March 3,2009 and March 26th,2009 have tested positive for a pseudomonas type species of bacteria. Under certain circumstances, after opening and closing a study on a CMS system while a study is still open on an in-room NX system, a problem of image mis-up can occur on the inroom NX system. The power supply have short circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the specific electrical outlet to trip. 1) In versions 1.1 and 1.1, the needle guide feature was to be disabled for all transducers but actually activated for 1215 transducer. 2) In non-cardiac application, can be an error in estimation of velocity when using pulsatility index tool which is sensitive to noise in spectral Doppler waveform causing mis-trace, user is unaware of miscalculations.
Kodiak Power Supply Acuson P50 Diagnostic Ultrsound System
Breg, Inc. Siemens Medical Solutions USA, Inc.
2009-08-03 2009-08-03
2009-06-18 49511 2009-06-19 49589
Type II Type III
3508, 3908, 4308, 4808 10120, 10122
Icelock expulsion valve 551 Stellant CT Dual Injector Systems P3T
OSSUR HF Medrad Inc.
2009-08-03 2009-08-03
2009-06-25 49594 2009-06-19 49618
Type II Type II
N/A 3007301, 3010432, 3014849
CO081010 N/A
The plastic cap on valve may detach from valve body breaking the vacuum and allowing the prosthesis to loosen or completely detach.
1. When P3T cardiac protocols are programmed with saline test inject and used in conjunction with ISI 700 or ISI 800 products and the Stellant CT Injection system, the pre-diagnostic protocol must include a transit bolus. 2. A defect in SW version 103.0 and 104.0 of the Stellant CT injection systems may cause ISI 700 accessory to incorrectly trigger bolus tracking on a Philips CT system for P3T cardiac protocol.
A) Cancellous Bone Screws B) Gap Plate Screw
2009-08-03
2009-07-03 49712
Type II
A) N/A B) N/A
A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer
Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. As such, areas of modified material properties may result, which may affect the intended use of the product. Although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material, the potential for variability of the material used in manufacturing the affected lots could compromise the strength. The third party supplier, for material used to manufacture the Restoration Modular Components, has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. As a precaution and due to the potential impact on the mechanical properties of the affected products, Stryker is recalling all products manufactured from material supplied by this supplier.
A) Restoration Modular Calcar Bodies B) Restoration Modular Hip Body/Bolt STD C) Restoration Hip Body/Bolt D) Restoration Mod. Hip Broach Body/Bolt E) Restoration Modular Conical Distal Stem F) Restoration Modular Conical Bowed Stem
2009-08-03
2009-07-03 49713
Type II
Paradigm Quick-Set Infusion Sets
Unomedical A/S
2009-08-03
2009-07-07 49737
Type I
A) T80998AA, T80998AC, T80550AA, T81105BA, T55344DA, T80551AA, T80554AA B) > 10 Numbers, Contact Manufacturer C) 29054602, 29110402, 28749101, 28932002, 28719201, 28914301, 29054902, 28932601 D) 29389202 E) CAXJ826A, CAXJ827A, CAXJ910A, CAXJ834A, CAXJ834C, CAXJ834J, CAXJA29D F) CAXJ951A MMT-396, MMT-397, MMT-398, MMT-399 > 10 Numbers, Contact Manufacturer A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A
'903' Newborn Screening Cards PCR AC-500/PCR AC-5000 Basic System
Whatman, Part Of GE Healthcare Philips Medical Systems DMC GMBH
2009-08-03 2009-08-03
2009-05-27 49796 2009-02-23 46769
Type III Type II
N/A MCR1511
Lot # 6828908, 6829008, 6818808 N/A
Apexpro Telemetry System - Transmitter Hispeed FXi, LXi System
GE Healthcare GE Healthcare
2009-08-03 2009-08-03
2009-02-20 45337 2009-01-13 45604
Type II Type III
APROCH-XX-XXX-XXX-X B7520AZ, B7530AZ
S/N RT908139180GA > 10 Numbers, Contact Manufacturer
CIC Pro Clinical Information Center
GE Healthcare
2009-08-03
2009-06-05 46547
Type II
CIC-XXXX-XXXXX-XXXXX*
A) Brilliance 40/64 Slice CT System B) Gemini TF PET/CT System 2.0 Compression L Plate, 6 Hole Left
Philips Medical Systems (Cleveland), Inc. Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
2009-08-03 2009-08-03
2009-07-16 46654 2009-06-29 49529
Type II Type III
A) 4550 110 02031 B) 4550 110 09021 62-5442
A) N/A B) N/A 24180
A) Sabouraud Dextrose Agar B) Middlebrook 7H11 Agar C) TSA + 5% Sheep Blood (BA) D) Nitrient Agar A) BHS 301 B) BHS 202 C) BHS 102 D) BHS 130 E) BHS 301 SCULPTOR F) BHS 302 G) BHS 135 H) BHS 140
PML Microbiologicals, Inc.
2009-08-03
2009-06-30 49558
Type III
Body Health S.A.
2009-08-03
2009-07-01 49781
Type II
A) 303434 B) P2377 C) P2600 D) P3889 A) BHS 301 B) BHS 202 C) BHS 102 D) BHS 130 E) BHS 301 SCULPTOR F) BHS 302 G) BHS 135 H) BHS 140
A) Posey Soft Belt With Crotch Strap B) Posey Breezeline Pelvic Holder Synchron Rheumatoid Factor (RF) Reagent
J. T. Posey Co. Beckman Coulter Inc.
2009-08-03 2009-08-03
2009-07-08 49840 2009-07-08 49912
Type II Type II
A) 4125C B) 4411 475136
A) 286801-1, 287425-1 B) 286811-1, 287223-1 C) 287232-1 D) 287173-1 A) 131108-0471, 131108-0472, 131108-0474 B) 160708-0134, 090408-0090 C) 080408-0082, 080408-0094, 120508-0112, 120508-0113, 120508-0114, 120508-0115, 120508-0107, 120508-0116, 120508-0106 D) 201207-0137 E) 181108-0179 F) 050208-0087 G) 140108-0238 H) 070607-0021 A) N/A B) N/A M802452, M804502, M807345, M808329
Approximately 2% of infusion sets in the affected lots (lots starting with 8) may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the vent does not work properly, this could result in too much or too little insulin being delivered. / Environ 2 % des dispositifs de perfusion des lots concerns (lots commenant par 8) ne permettent probablement pas la pompe insuline de sarer convenablement. Laration est ncessaire pour pressuriser le compartiment de la seringue, o est insr le rservoir, par rapport lair ambiant. Si la bouche daration fait dfaut, il peut en rsulter une administration excessive ou insuffisante dinsuline. Partial or complete detachment of the '903' paper from the demographic portion of the '903' newborn screening card may occur, which may necessitate a re-screening. Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS. Potential for intermittent or unpredictable circuit board failures due to insufficient copper plating resulting in loss of communication and patient data. X-ray leakage from diagnostic source (tube + collimator) exceeded 21CFR regulatory requirement and IEC standard. Concerns of increased patient exposure due to leakage of radiation. Large number of time change requests between two or more CARESCAPE devices may result in sluggishness of CIC Pro, loss of waveforms, parameters & alarming and inconsistent time values. There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved based upon their series ID. The possibility of part number 62-5442 2.0 Compression l Plate, 6 Holes Left package may have contained a similar part 62-5441 2.0 Compression l Plate Right instead of the 62-5442 part. Specific lots of prepared plated media may be experiencing random fungal contamination.
A notification was sent to the distributor informing them that the medical devices that were sold to them by Body Health S.A. were not licensed in accordance with the medical devices regulations.
Label clarification. As the Synchron RF Rreagent ages, it may fail calibration with the condition of "math error" on the calibration report. Real time testing in manufacturing indicates the stability claim of 24 months will not be met for lot numbers: M802452, M804502, M807345 and M808329. Calibration failures occur at 12 months.
AW Volumeshare2 - CT Perfusion 4
GE Healthcare
2009-08-03
2009-06-16 48164
Type II
5189396
Fetal Bleed Screening Test
Immucor Inc.
2009-08-03
2009-07-01 49726
Type II
7892
17411
A) Pediatric Emergency System Kit B) Pediatric Emergency System Flying Carpet C) Emergency System Intraosseus Module
Vital Signs Inc.
2009-08-03
2009-06-30 49853
Type II
Fogarty Occlusion Catheter
Baxter Healthcare Corporation, Edwards Critical-Care Division Ormco Corporation Medtronic Inc.
2009-08-03
2009-06-29 49905
Type II
A) 7730ALS, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5 B) 7730FLY C) 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2 62080822F
A) 245F to 366F inclusive, 001K to 149K inclusive B) 001K to 149K inclusive, 245F to 366F inclusive C) 245F to 366F inclusive, 001K to 149K inclusive
When using CT Perfusion 4 algorithm on data with longer time sampling intervals, under certain conditions, the noise level in the functional maps may prevent user from clearly seeing a subtle perfusion defect. Complaints of particulate matter in the indicator cells, positive and negative control components of the test kit. An investigation has confirmed microbial contamination in one vial of indicator cell. The Broselow/Hinkle Intraosseus Module, which is part of the Broselow/Hinkle Pediatric Emergency System, contains a 15g intraosseus needle that is not compatible with the IV extension set that is provided in the module. This may result in a leak at the connection, delaying treatment.
Two parts of the tubular packaging could become loose under the shrink wrap that holds the directions for use insert on the packaging tube and could render the product non-sterile. Damon SS Archwire 227-1029, 26 mm, mislabeled as 227-1043, 40 mm. Reduced battery performance (estimated at 2.1% of affected population) has resulted in 8 occurrences of low battery reset between 47 and 56 months, and 1 occurrence of premature elective replacement indicator (ERI) at 54 months post-implant. For affected pumps, the minimum time frame of 90 days between ERI and end of service (EOS) may also be reduced. The manufacturer identified a reduction of the on board stability from 42 days to 14 days for the Hitachi Tina-quant Apolipoprotein A1 reagent when used on the Roche Hitachi 912 and 917 and MODULAR P systems. Trinity Biotech initiates a corrective field action for TriniCAL Reference Plasma, product code T5102 (lots R332037, R332037R and S287001). The protein C chromogenic value is misassigned in these lots and can result in an erroneous protein C chromogenic activity result. Precision and open vial stability issues with this lot may result in increased or decreased aPTT times across the range of the assay. The lot is not stable for the full 30 day period when opened and stored at 2-8 c as recommended. Precision issues with this lot may result in increased aPTT times across the range of the assay. The negative control shows an elevated signal. It can exceed the upper quality control limit of 0.200 OD given in the directions for use. The unit package seals on the BD 60 ml Luer lock syringes, a component of the Cardinal Health custom sterile packs may have been adversely affected as a result of an issue during the packaging process. On Clinacs running C- series version 7.X, the couch can be moved via the float mode when the stereotactic motion disable function is turned on. This may represent a hazard to a stereotactic patient with a head ring mounted on a floor stand or pedestal. Biosite, Inc. initiates notice of correction for Triage TOX Drug Screen Kit, PN 94400. Boxes shipped after August 6, 2008 are misprinted on the right side of the box flap. The misprint incorrectly states "use EDTA whole blood or plasma sample only". The kit is intended for use with urine samples not blood or plasma. Abbott Clinical Chemistry Total Bilirubin (6L45) demonstrated under-recovery on one clinical neonatal specimen resulting in a value less than the linear limit. A linear high flag (LH) was therefore not generated. The specimen was known to have a bilirubin concentration higher than the linear limit. If the radius drive assembly on the detectors of Brightview Gamma Cameras is severely compromised, the detector may slide, under the influence of gravity, to its hardware limit. The nonconforming devices were comingled during the manufacturing process. For lot KNRU, there are devices in unit boxes with labels marked size 4 and devices marked '514.0400, size 4', that are actually size 3. For lot KNTK, there are devices in unit box Operator manual does not contain description of a re-sterilization process for reusable biopsy metal needle guides for the stereotactic positioner. Various forms of system lockup or display screen "freezes" can occur. Surgical monitoring has a remote probability that a lockup could cause any permanent impairment of the body function or permanent damage to a body structure. Proper validation was not performed on using the headset in an inverted (upside down) manner as described in the noted system's operators manual. MIS Diamond Burs have the potential to deform and fracture at speeds above 50,000 rpm. A site reported that their End-to-End targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robot controller. This discrepancy caused the CyberKnife Treatment Delivery There is a variation in the SmartMonitor 2 manufacturing process that could allow the wire harness attached to the alarm to be pinched between the upper and lower case of the SmartMonitor 2 units. If the wire harness is pinched such that the conductive wi
Damon SS Archwire 227-1043 Synchromed II Implantable Infusion Pump
2009-08-03 2009-08-03
2009-05-01 49956 2009-07-14 49972
Type III Type II
227-1043 8637
20994915 > 100 Numbers, Contact Manufacturer
Tina-quant a Apolipoprotein A1
Roche Diagnostics GMBH
2009-08-03
2009-07-17 49761
Type III
3032612122
All Lot Numbers
Trinical Reference Plasma T5102
Trinity Biotech PLC
2009-08-03
2009-05-21 49894
Type II
T5102
R332037, R332037R, S287001
Triniclot APPT S, Cat. No. T1202
Trinity Biotech PLC
2009-08-03
2009-04-23 49895
Type II
T1202
S067009
Trinclot APTT HS, Product Code T1204 Varelisa MPO ANCA A) Bypass TGH Kit B) Valve TGH Kit Clinac IX Radio Therapy Delivery System
Trinity Biotech PLC Phadia GMBH Cardinal Health
2009-08-03 2009-08-03 2009-08-03
2009-05-25 49896 2009-04-09 49897 2009-07-13 49952
Type II Type III Type II
T1204 17696 A) PC30CG'XXX' B) PC30VP'XXX'
R324001 32
2009-08-03
2009-05-29 50003
Type II
A) 870139, 878608, 866059, 874187, 876386, 882391, 888414 B) 878586, 866060, 874182, 874678, 884383 2100C, 21EXS, CLINAC IX H14, CLINAC > 10 Numbers, Contact Manufacturer IX H27, CLINAC IX H29 94400 > 10 Numbers, Contact Manufacturer
Triage Tox Drug Screen PN 94400
Biosite Incorporated
2009-08-03
2009-05-29 50030
Type III
A) Aeroset System - Total Bilirubin Assay B) Architect System - Total Bilirubin Assay
2009-08-03
2009-07-10 49921
Type III
A) 6L45-20, 6L45-40 B) 6L45-20, 6L45-40
A) All Lots B) All Lots
Brightview Gamma Camera Sy. w/ 3/8" Crystal & Detector Caudal Cephalic Uniglide Femoral Component, Non-Cemented
2009-08-03
2009-07-14 49947
Type II
2170-3002A
N/A
Corin Limited
2009-08-17
2009-07-20 49985
Type II
514.0300, 514.0400
KNRU, KNTK
Reusable Metal Needle Guides & Bushings Sonara Transcranial Doppler System
GE Healthcare Cardinal Health 209, Inc. DBA Viasys Healthcare Inc, Viasys Neurocare
2009-08-17 2009-08-17
2009-04-30 48986 2009-02-11 49919
Type I Type II
N/A 982A0470
> 10 Numbers, Contact Manufacturer PWH0201
Instatrak 3500 System MIS Diamond Burs Cyberknife Robotic Radiosurgery System
GE OEC Medical Systems Inc. Stryker Instruments Accuray, Inc.
2009-08-17 2009-08-17 2009-08-17
2009-07-23 49926 2009-07-13 49950 2009-06-22 50114
1006236-001
S/N'S IT35079, IT35214P, IT35226P
8420-107-120, 8420-107-125, 8420-107- > 10 Numbers, Contact Manufacturer 130, 8420-107-135 27600 C185
Smartmonitor 2 With PCMCIA
Respironics Inc.
2009-08-17
2009-05-11 48114
Type I
4002, 4003
S/N: 3000033364 to 3000038740
Twin-Pass Dual Access Catheter
Vascular Solutions, Inc.
2009-08-17
2009-07-02 49872
Type I
5200
Easylink Informatics System
2009-08-17
2009-07-20 49974
Type II
100034941
All Versions
A) Advia Centaur B) Advia Centaur XP Updated recall # 49196 previously posted on 200907-06. Factor V Leiden Kit on LightCycler 2.0
2009-08-17
2009-06-10 49196
Type III
A) 07566733 B) 07566733
A) 37820027, 38129027, 38386027, 39195027 B) 37820027, 38129027, 38386027, 39195027
3 occurrences of catheters containing a piece of PTFE beading material in the OTW lumen have been reported. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior Inaccurate results reported to the system when a sample is diluted and placed back into the system without assigning the sample a unique, different, sample ID. As a result, patient sample results may be reported with an incorrect result value resulting in Manufacturer has determined that specific lots have shown decreased specificity for negative populations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies Possible failure of the factor V Leiden control template (positive control) included in the factor V Leiden Kit for use with the LightCycler 2.0 instrument. The factor V Leiden control template may fail to meet the validity criteria set by the macro compo Upgrades initiated to avoid potential problems: pinch points and binding of release mechanism on headrest adaptors, floorlock retracting to unlock position, CPU errors involving involuntary table movements. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, causing therapy to be delayed or Table lock safety features are not always being utilized by the users and have resulted in unintended lateral movement that may impact patient safety. Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. As such,
Roche Molecular Systems, Inc
2009-08-17
2009-07-24 49994
Type III
36101790001
14674120
Operon D850/750/752/B810 Surgical Table
Berchtold Medizen-Elektronik GMBH
2009-08-17
2009-02-03 50000
Type III
B 810, D 750, D 752, D 850
3272-O10001, 3270-O10002, 3261-O10036
Welch Allyn AED10 Defib, MRL Jumpstart
Welch Allyn Protocol, Inc.
2009-08-17
2009-07-30 50054
Type II
970300E, 970302E, 970302F, 970308E, 970311-E 2208203, 2225864, 2225881
Compax 40E Table A) Cancellous Bone Screws B) Gap Plate Screw Update recall # 49712 previously posted on 200908-03.
GE Medical Systems LLC Howmedica Osteonics Corporation
2009-08-17 2009-08-17
2009-07-31 49649 2009-07-03 49712
Type II Type II
59658ES5, 63221ES6, 69850MA6, 64076ES3
A) > 10 Numbers, Contact Manufacturer A) 2080-0015, 2080-0020, 2080-0025, 2080-0030, 2080-0035, 2080-0040, 2080- B) > 10 Numbers, Contact Manufacturer 0045, 2080-0050, 2080-0055, 2080-0060 B) 2030-6516, 2030-6520, 2030-6525, 2030-6530, 2030-6535, 2030-6540, 20306545, 2030-6550, 2030-6555, 2030-6560 A) 53000-E1, 53000-F1 B) 5300P-E1, 5300P-F1 C) 530T0-E1, 530T0-F1 D) 530TP-E1, 530TP-F1 E) 53N00-E1, 53N00-F1, 53S00-E1, 53S00-F1 F) 53N0P-E1, 53N0P-F1,53S0P-E1, 53S0P-F1 G) 53NT0-E1, 53NT0-F1, 53ST0-E1, 53ST0-F1 H) 53NTP-E1, 53NTP-E1R, 53NTP-F1, 53STP-E1 71117083 A) 8600, 8650 B) 8015 C) 8120 D) 8300 E) 8000APM, 8100LVP F) 8210, 8220 G) 8110 A) 2335129 B) S1872LC A) All Serial Numbers B) All Serial Numbers C) All Serial Numbers D) All Serial Numbers E) All Serial Numbers F) All Serial Numbers G) All Serial Numbers H) All Serial Numbers
A) Vital-Signs Monitor with Rate and Map B) Vital-Signs Monitor with Rate/Map Printer C) Vital-Signs Monitor with Rate/Map/Printer/Temp D) Vital-Signs Monitor with Temp and Printer E) Vital-Signs Monitor with Nellcor F) Vital-Signs Monitor with Nellcor SP
Welch Allyn Protocol, Inc.
2009-08-17
2009-08-04 49917
Type II
Speakers in VSM300 Vital-Signs Monitor failed to produce sound. The failure of the speaker eliminates audio alarm tones for parameter violation, equipment alerts, or error codes, as well as repetitive beeps to indicate pulses when monitoring SP02 (oximetr
4.0mm Direct Measuring Gauge A) Alaris Patient Care System-ID Module B) Alaris Patient Care System-Server Module C) Alaris Patient Care System-PCA Module D) Alaris Patient Care System-ENTDAL CO2 E) Alaris Patient Care System-Pump F) Alaris Patient Care System-SPO2 Module G) Alaris Pa A) Innova 4100 IQ - Main Unit B) Innova 2000 Cardiovascular System
Smith & Nephew, Inc. Cardinal Health
2009-08-17 2009-08-17
2009-07-15 49969 2009-07-28 49979
Type II Type II
GE Medical Systems SCS
2009-08-17
2009-07-31 49983
Type II
A) Innova 4100 IQ - Main Unit B) Innova 2000 Cardiovascular System
2009-08-17
2009-07-31 50099
Type II
A) 2335129 B) S1872LC
Delta Ceramic Ball Heads
2009-08-17
2009-07-27 50100
Type II
18-3200
A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer C) > 10 Numbers, Contact Manufacturer D) > 10 Numbers, Contact Manufacturer E) > 10 Numbers, Contact Manufacturer F) > 10 Numbers, Contact Manufacturer G) > 10 Numbers, Con A) 417372BU0, 405584BU4, 432687BU2, 406451BU5, 429328BU8, 437542BU4, 398530BU6 B) 409881BU0, 397054BU8, 419496BU5, 427075BU7, 417895BU0 A) 417372BU0, 405584BU4, 406451BU5, 398530BU6 B) 397054BU8, 349890BU4, 347469BU9, 419496BU5, 354853BU6, 417895BU0, 364939BU9 28635501, 28575801
All Prior To 2009 Excluding 08KM20464 & Excludi The markings on the gauge are incorrect. The discrepancy may not be apparent to the user and could result in incorrect placement of the K-wire. 1) Occluded tubing may cause medication not to be delivered. 2) Misprogrammed infusion caused by ignoring the warning message. 3) Specific ESD protection circuitry may result in an over or under infusion. 4) Certain fluids solidify in the pumping mechanis
A potential power supply failure inside the GE equipment cabinet could occur with no warning & prevent x-ray generation & image processing. If this occurs, the system cannot be restarted.
Potential video splitter failure inside GE equipment cabinet could occur with no warning & prevent x-ray image display. System cannot be recovered without service intervention.
The third party who supplies Delta Ceramic Ball Heads did not comply with its specifications. The spherical diameter feature was measuring out of specification (oversized). Some humidifiers may fail to operate due to a potential malfunction of the internal connection between the heater plate and the circuit board which results in a blinking blue light on the control knob. Active Cortisol Elisa Kits will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. Contrast-enhanced 3D TOF MRA peripheral run-off studies show significant vasculature shading and right/left asymmetry, which could subject the patient to additional non-invasive examinations.
M Series Remstar Heated Humidifier System
Respironics Inc.
2009-08-17
2009-07-31 50202
Type II
Active Cortisol Enzyme Immunoassay Kit 3.0T Signa HDX MR System - Hardware
Diagnostic Systems Laboratories Inc., DSL GE Healthcare
2009-08-31 2009-08-31
2009-07-20 50075 2009-08-04 48251
Type II Type II
1049109, 1049110, 1049124, 1051157, 1051158, R1049109, R1049110, U1049109, U1049110 DSL-10-2000 M3335PF
N/A
> 10 Numbers, Contact Manufacturer WB0029
A) Stryker Pain Pump 120cc Catheters B) Infusion Sets For Stryker Pain Pumps C) Stryker Pain Pump 270cc Catheters D) Exfen Catheters E) Stryker Pain Pump II Infusion Sets F) Stryker Pain Pump2 Kits
Stryker Instruments
2009-08-31
2009-06-23 49458
Type II
A) Dyonics Powermax Elite Motor Drive Unit B) Dyonics Mini-Motor Drive Unit C) Dyonics Power Ultralight Motor Drive CyberKnife Robotic Radiosurgery System
Smith & Nephew, Inc., Endoscopy Division
2009-08-31
2009-07-26 50208
Type III
Accuray, Inc.
2009-08-31
2009-06-22 50252
Type II
A) 0500-100-000, 0500-110-000, 0500120-000, 0500-120-025, 0500-140-000 B) 0500-200-000, 0500-250-000 C) 0501-100-000, 0501-120-000, 0501140-050, 0501-416-050 D) 0500-050-000, 0525-010-000 E) 525-250-000, 525-500-000 F) 0525-125-000, 540-155-000 A) 72200616 B) 7205357 C) 7205971 28000
A) All Lots B) All Lots C) All Lots D) All Lots E) All Lots F) All Lots
There is the potential for the catheter to break. Additionally there is the potential for the painpump to under-infuse pain medication.
A) N/A B) N/A C) N/A C202
A customer has reported that pieces of tissue remained within a Smith & Nephew shaver motor drive unit (hand piece) after the cleaning process had been completed prior to sterilization. A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) and error 3 Manufacturer has identified a defect, a rough square finish to the scissor tips rather than a smooth tip, could cause damage to the inner wall of the blood vessel rendering it unsuitable for bypass graft. Microbial contamination of Anti-Cardiolipin IGM positive control (lot CPM-591). Calibrator 3, lot CLM3-156, may also be affected. These lots are included in Anti-Cardiolipin IGM Test Kit, lot CL-863 only. The wash concentrate tube assembly may fail to deliver the appropriate amount of wash concentrate on some Synchron DXC systems due to an accumulation of crystals. This action is being conducted because the potential exists for residual buffing compound to be present on the surfaces of the femoral head. A potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as taphylococcus aureus. 48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel. Potential of false positive reactions (blue agglutination) for salmonella E or G serogroups with reagent # 2 included in the kits. May produce weak positive or false negative results. An error code (code 13) is displayed on some of the consoles when a stylus or EHS hand piece is connected to the integrated power console (IPC) indicating that the hand piece has not been recognized by the console. When this happens the stylus or EHS HP i The Lasertek 5000 has been classified as a class II device in Canada. This device is not currently licenced for use in Canada. In a specific case, the TDWorkstation sends the total protein result to the instrument for a wrong patient. Software defect 24578. The cleaning procedure as recommended in the instrument's manual can lead to falsely elevated PT/INR results. This procedure may include liquid into the meters which can lead to the creation of electrical bridging between heater pins. Reduction on the measuring range from 7-100 u/ml to 7-500 u/ml for the product Anti-CCP Reagent Kit. It has come to the attention of Teleflex that the tether attaching to the double swivel cap may partially or completely break at the attachment points. The broken tether may lodge inside the dual swivel tubing or body during shipment to the end user resu In certain external transport use environments, the mechanical/electrical connection between the pads therapy cable (including pads/CPR cable) and the Heartstart MRX Defibrillator/Monitor may wear at an increased rate. Without routine operational checks, The manufacturer has determined there is a possibility that the device may not shut off if the ablate button is released. Manufacturer has determined there is the possibility that the device may not fully retract once it is deployed.
Teleflex Medical Surgical Scissors
Teleflex Medical
2009-08-31
2009-07-06 49787
Type II
352164, 352165, 352166, 352167, 352168, 352169, 352178 425-2020
RR8, SS8, TT8, UU8, VV8, WW8, XX8, MM9, WW7, XX7, MM8, NN8, OO8, PP8, QQ8 CL-863
Anti-Cardiolipin IGM Test Kit
Bio-Rad Laboratories Diagnostics Group
2009-08-31
2009-07-27 50175
Type II
A) Tube Assembly 142, V2, V12, For DXC 600 B) Tube Assembly 142, V2, V12, For DXC 800 C) Tube Assembly 142,V2,V12, For DXC 600i Versys Hip System Femoral Head Staphaurex Plus 150/450 Test Kits VGM 19" Monitor Updated recall # 48079 previously posted on 200905-25. Wellcolex Colour Salmonella Oxidase Touch Sticks A) Integrated Power Console (ENT) B) Integrated Power Console (NT)
2009-08-31
2009-07-27 50231
Type II
Zimmer Inc. Remel Europe Ltd. Welch Allyn Protocol, Inc.
2009-08-31 2009-08-31 2009-08-31
2009-08-06 50277 2009-03-27 50094 2009-04-21 48079
A) 4764, A10038 B) 4764, A10038 C) 4767, A10038 801802802 N/A VG930M
A) All Serial Numbers B) All Serial Numbers C) All Serial Numbers 60378581 J477610, J359510 S/NS > QC2082880001
Remel Europe Ltd. Oxoid Limited Medtronic Xomed
2009-08-31 2009-08-31 2009-08-31
2009-04-03 50093 2009-04-20 50095 2009-07-27 50207
RE30858301, RE30858302 N/A A) 1898001 B) EC300
J438110, J438910 657819, 660081, 669024, 680190, 682455 A) 71358, 71360, 71357, 71361 B) 51033, 51356, 51508
Lasertek 5000 TDWorkstation Working With Sebia Hyris A) CoaguCheck XS Instrument B) CoaguCheck XS Plus Monitor Elecsys Anti-CCP reagent Kit A) Sheri-I-Bronch Endobronchial Tube Kit B) Sher-I-SWIV Double Swivel Tracheal Tube
Scalp Laser Technidata S.A.S. Roche Diagnostics GMBH
2009-08-31 2009-08-31 2009-08-31
2009-07-10 50348 2009-07-26 50203 2009-08-13 50168
N/A TD-WST-01 A) 3666794 B) 04800842190 5031656190 A) 5-16028, 5-16035, 5-16037, 5-16039, 5-16041, 5-16128, 5-16135, 5-16137, 516139, 5-16141 B) 5-15301, 5-15401 M3536A
N/A V.11.11.A, V.12.51.A, V.12.61.A A) All Serial Numbers B) All Serial Numbers Lots #153989 And Above A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer
Roche Diagnostics GMBH Teleflex Medical
2009-08-31 2009-08-31
2009-07-31 50171 2009-07-31 50274
Type III Type I
Heartstart MRX Defibrillator/Monitor
Philips Medical Systems
2009-08-31
2009-07-02 50290
Type II
Lightwave Ablator IA-2000-S
Linvatec Corporation D.B.A. Conmed Linvatec
2009-08-31
2009-08-05 50376
Type II
IA-2000-S
Conmed Linvatec Arthro-Knife
2009-08-31
2009-08-05 50381
Type II
> 10 Numbers, Contact Manufacturer (Numbers With Expiration Dates From July 2009 to Sept. 2013) 70-0071-103, 70-0071-113, 70-0072-003, > 10 Numbers, Contact Manufacturer (Lot #'s 70-0073-003, 70-0074-103, 70-0075-003, With Expiration Dates Of July 2009 to August 70-0076-003, 70-0077-103, 70-0078-103 2013) TSX-301A/2 > 10 Numbers, Contact Manufacturer
Aquillion One
Toshiba Medical Systems Corporation
2009-08-31
2009-08-11 50342
Type II
Clearview HCG
Unipath Limited
2009-08-31
2009-06-29 50405
Type II
506788
All Lot Numbers.
Sireskop SX/SD Updated recall # 47071 previously posted on 200906-22. Cook Sydney IVF Culture Oil
Siemens AG
2009-09-14
2009-02-11 47071
Type III
10093754, 31 11 676, 3111668
21005, 21040, 21087, 21107, 21110, 31036, 34170, 36103, 41021 A833541
William A. Cook Australia, PTY. Ltd.
2009-09-14
2009-03-31 47702
Type II
K-SICO-200
In Aquilion One System, due to the problem of software and other, a part of the imagerelated information may be abnormal, or an error may occur at the time of scan setup when sure exposure 3D is used. The manufacturer has updated the instructions for use to state "read the result at 3 minutes. Do not interpret the result after 3 minutes". Previously the instructions allowed tests to be read up to 10 minutes. Penetrating liquids or sprays entering the system may lead to malfunction of the system, resulting in unintentional movement, unintentional radiation, extended radiation or useless image, endangering the patient or operator. Higher than usual viscosity of culture oil may lead to difficulty in culturing. Communication issued to affected facilities but no product return requested.
A) Van Sonnenberg B) Flexima Hydrophilic All Purpose C) Flexima Hydrophilic Drainage D) Flexima Hydrophilic Biliary Drainage E) Flexima Hydrophilic Drainage Kit F) Flexima Hydrophilic Nephrostomy G) Flexima Hydrophilic Nephrostomy Catheter H) VTC Nephrost InterDry Ag
2009-09-14
2009-03-23 47710
Type III
Coloplast A/S
2009-09-14
2009-07-28 50228
Type II
A) 20-307, 21-306, 21-307, 27-303, 27304, 27-315, 27-316 B) 27-124, 27-131, 27-132, 27-133, 27134, 27-135 C) 27-196, 27-197, 27-198, 27-199 D) 27-154, 27-155, 27-156, 27-157, 27158, 27-159, 27-160, 27-161, 27-162, 27260, 27-261, 27-262, 27-263, 27-264 7910
A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer C) > 10 Numbers, Contact Manufacturer D) > 10 Numbers, Contact Manufacturer E) > 10 Numbers, Contact Manufacturer F) > 10 Numbers, Contact Manufacturer G) > 10 Numbers, Contact Ma 1789435
Boston scientific has decided to revise the DFU for all affected products to include more detailed info about sutures separating from catheter.
A) VNS Demipulse SYS Programming B) VNS Demipulse SYS Programming Software A) Gyroscan Intera ACS 1.5 Tesla MR System B) Intera 1.5T MR Systems - Coils Aquesure Disposable Filters
Cyberonics Inc.
2009-09-14
2009-08-11 50356
Type II
A) 250 (Versions 6.1 And Less) B) 250, 250 V7.1.4 A) N/A B) N/A N/A
2009-09-14
2009-08-14 50406
Type II
Bomimed Inc.
2009-09-14
2009-04-30 50420
Type II
Magna-FX Cannulated Screw Fixation
Zimmer Inc.
2009-09-14
2009-08-14 50432
Type III
114607000
Hydrodissector Cannulas
Hurricane Medical
2009-09-14
2009-05-14 50440
Type II
4027
Ultrapower Diamond Wheel Bur
2009-09-14
2009-08-04 50380
Type II
7021-092, 7021-292, 7021-393
Datex Ohmeda Carestations Interface
GE Healthcare Finland OY
2009-09-14
2009-04-14 47422
Type II
M1079844
Coloplast became aware of an InterDry AG stability test failure in that a sample submitted for testing contained no silver. Only a portion of 1 lot did not meet product specifications for silver content. A) All Versions And Lot Numbers In rare instances, a system diagnostic test using model 250 programming software (v 7.1 B) All Versions And Lot Numbers and earlier) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering the A) 5354, 5220, 5418, 99220, 5572, 5465, 5438 The combined use of the Synergy Flex-M/Shoulder Coil 1.5T with other coils increases the B) 8985, 10236, 8256, 22658, 8672, 8442, 8379, chance of RF interaction and heating up of the coil. This may result in possible burns of the 8240, 10183, 10566 patient. This applies to all Intera 1.5T and Gyroscan Intera ACS 1.5T MR 042709, 042309, 042209 A customer could not get a CO2 tracing while the anesthesia circuit was in use because the CO2 port on the filter was blocked with the plastic mould. Lot numbers listed are the affected anesthesia circuits. 60471710 Some units in the affected lot of Magna-FX Cannulated Screw Fixation System cannulated bone screws may not have the hex broached into the head of the screw, making driver engagement impossible. 90402 It was discovered during final review of the product 4027, lot 090402 that the wrong product was issued for packaging. A similar ophthalmic cannula, product 2027 was inadvertently retrieved and packed as a product 4027. > 10 Numbers, Contact Manufacturer This device ID was included because of the error on device ID #23037. The catalogue # 7021-392 was wrongly listed under device ID 406636 instead of 406639. Company already have send corrective fax-back to MDB. > 10 Numbers, Contact Manufacturer The N-DISVENT-02 acts as an interface between the anesthesia machine or ventilator and the patient monitor. Because of incorrect patient weight and/or height synchronization between anesthesia machine/ventilator and the patient monitor through the N-DISVE A) All Versions And Lot Numbers B) All Versions And Lot Numbers > 10 Numbers, Contact Manufacturer 10037, 10169, 10014, 10072, 10130, 101212, 110009, 110129 8192744, 8288054 In rare instances, a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering the Possibility of thermal injury to patient resulting from fluid leakage at the cervix around the sheath. During radiation treatment the usual data were not visible on the operator station display, even though the rad on indicators were active. The treatment was then stopped at around the 4min mark, but the system did not mark the treatment as interrupted. Wh Latch bar on centrifuges may have been improperly assembled. May become loose, disabling safety feature which prevents customers from opening centrifuge while it is spinning. A problem may occur when an order of long duration (those continuing for several days) is discontinued. Due to the configuration of the buffer storage in local memory it may not set the status of the future tasks to "done". In this rare instance it will c A recent modification to Pedicap end-tidal co2 detector may result in increased resistance to airflow through Pedicap and may cause ineffective ventilation of patient and inadequate detection of co2 levels, so that the indicator paper will not change colo After a brief intense fire in a neonatal unit in the United States, an ECRI investigations concluded the stabilet was the ignition source for the fire. Letter to inform all customers on how volume flow calculations are calculated on the affected ultrasound systems and that the formulas determining flow volume are described in the included manual addendum. The metal shim between the jaws may detach during the procedure and fall into the surgical field. It has been reported that the detached shim may be undetected and be left behind in the patient.
A) VNS Model 250 Programming Software B) VNS Demipulse System Programming Software HTA System Hi-Art System
Cyberonics Inc.
2009-09-14
2009-07-31 50356
Type II
A) 250, 250 V7.1.4 B) 250 (Versions 6.1 And Less) M006550160, M006550161, M006560200, M006560201 101264
Boston Scientific Microvasive Tomotherapy Incorporated
2009-09-14 2009-09-14
2009-08-05 50466 2009-08-13 50472
Type II Type II
Clay Adams Dynac III Centrifuge
Becton Dickinson And Company
2009-09-14
2009-08-17 50475
Type III
420104
A) Anesthesia Manager B) PACU Manager C) Critical Care Manager Pedicap / Pedicap 6
Picis Inc.
2009-09-14
2009-08-10 50507
Type II
Covidien LP - Respiratory & Monitoring Solutions GBU
2009-09-14
2009-08-18 50527
Type I
A) Model/Catalog #: 4220 B) Model/Catalog #: 4245 C) Model/Catalog #: 1110 Pedicap, Pedicap 6
A) S/W version 7.1 B) S/W version 7.1 C) S/W version 7.1 > 10 Numbers, Contact Manufacturer
Warmer, Infant Radiant G40, X150, X300 Ultrasound System
Draeger Medical Systems, Inc. Siemens Medical Solutions USA, Inc.
2009-09-14 2009-09-14
2009-07-20 50549 2009-08-12 50581
Type I Type III
1250, 1500, 200, 2000, 2000/3000, 2200/3200, 300, 3000, 3200, 79 FMT 8648375
All Serial Numbers 302351, 303316, 300477
A) PKS Seal Open Forceps, Curved Jaw With Cord B) Plasmakinetic Curved Jaw Open Forceps C) Plasmakinetic Straight Jaw Open Forceps D) Plasmakinetic Angle Jaw Open Forceps
Gyrus Acmi, Inc.
2009-09-14
2009-08-18 50595
Type II
A) 915000PK, 915005PK, 915010PK B) 3103PK C) 3104PK D) 3105PK
A) All Lots Prior To 2009-08-14 B) All Lots Prior To 2009-08-14 C) All Lots Prior To 2009-08-14 D) All Lots Prior To 2009-08-14
A) Expo Angiographic Catheters, amplatz B) Impulse Angiographic Catheter, amplatz C) Impulse Angiographic Catheter, brachial D) Impulse Angiographic Catheters,femoral E) Impulse Angiographic Catheters,internal F) Impulse Angiographic Catheters,left G) Imp
2009-09-14
2009-08-07 50383
Type II
A) 08526-01 B) 16391-100 C) 16391-11 D) 16391-02 E) 16391-201 F) 16391-190 G) 16391-117 H) 16391-174 I) 16391-40 J) 16391-180 K) 16391-203 L) 08526-150 M) 08526-21 N) 08526-01 O) 08526-201 P) 08526-190 Q) 08526-146 R) 08526-40 S) H749085263002 T) 08526-1
A) Wiseguide Guide Catheters, bypass B) Wiseguide Guide Catheters, multipurpose C) Wiseguide Guide Catheters, q-curve D) Wiseguide Guide Catheters, radial E) Wiseguide Guide Catheters, contralateral F) Wiseguide Guide Catheters, cls G) Wiseguide Guide Cat MC5057 Universal Cable
2009-09-14
2009-08-07 50383
Type II
2009-09-14
2009-08-14 50401
Type II
A) 16320-122 B) 16320-131 C) 16320-293 D) 19500-474 E) 16320-573 F) 16320-573 G) 16320-583 MC5057
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A J) N/A K) N/A L) N/A M) N/A N) N/A O) N/A P) N/A Q) N/A R) N/A S) N/A T) N/A U) N/A V) N/A W) N/A X) N/A Y) N/A A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A N/A
Sterile barrier in the packaging may be compromised.
Sterile barrier in the packaging may be compromised.
The possibility that a sufficiently worn/damaged Universal Cable MC5057, when used with various Conmed Linvatec electric handpieces may cause the handpiece to self activate. The foot control cable lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions exceeding CISPR11. Failure to apply and verify an adequate jaw-shaped field size and field position at the linac for the used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator may lead to serious injury or death of the patient Power cords may crack and fail leading to potential risks of electrical shock. Delay in setup and therapy interruption and fires which may also occur in an oxygen-rich environment.
Emax 2 Plus System - Foot Pedal A) Brainscan Radiotherapy System-Software B) iPlan RT Dose-Planning Software A) Oximetrix 3 System SO2/CO Computer B) Lifecare PCA 4100 Plus Infuser C) Lifecare 5000 Plum Infusion Pump System D) Plum XL E) Omni Flow 4000 Plus IV Medication MS F) Plum XL Micro/Macro With Data Port XLD G) Plum XL Micro/Macro Infusion (XLM) H) Plu
The Anspach Effort Inc. Brainlab AG
2009-09-14 2009-09-14
2009-08-17 50456 2009-08-12 50497
Type II Type I
EPLUS-FP A) 20630 B) 20630 A) 50130 B) 1950 C) 2507 D) 11555 E) 40051 F) 11859 G) 11846 H) 11781 I) 186706 J) 13075 K) 12384, 20709 L) 11971, 12391, 20679, 20792 M) 12618, 20678 64999, 65050 (Syringe) A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A M00448100, M00448110, M0048400
SN C08301701901 A) N/A B) N/A A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A J) N/A K) N/A L) N/A M) N/A N/A A) > 100 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer C) > 10 Numbers, Contact Manufacturer D) > 10 Numbers, Contact Manufacturer E) > 10 Numbers, Contact Manufacturer F) > 10 Numbers, Contact Manufacturer G) > 10 Numbers, Contact M > 10 Numbers, Contact Manufacturer
Hospira Inc.
2009-09-14
2009-08-20 50517
Type II
Galileo 500ul Syringes A) Screwplant Implants B) Screwplant Healing Collars C) Legacy Healing Collars D) Screwindirect Implants E) Screwplus Implants F) Screwdirect Implants G) Replant Implants H) Replus Implants Cobra Electrosurgical System
Immucor Inc. Implant Direct LLC
2009-09-14 2009-09-14
2009-08-11 50526 2009-08-18 50598
Type II Type II
The glue joint between the glass and the metal can be insufficient on some syringes, which can lead to leaking and possibly to breakage of the glass barrel. Cover caps exhibited visible cracks post sterilization.
Boston Scientific EP Technologies
2009-09-14
2009-08-05 50601
Type II
Potential to deliver RF energy without depressing the foot switch. If foot switch is not depressed, and the audible sound is heard and/or the indicator light is on, the foot switch is not functioning properly.
A) Portex Tracheal Tube, Oral/Nasal, Ivory B) Portex Tracheal Tube, Siliconised C) Portex Tracheal Tube,Murphy,Siliconised D) Portex Polar Preformed Tracheal Tube E) Portex Tracheal Tube, Oral/Nasal F) Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
Smiths Medical International Ltd.
2009-09-14
2009-09-14 50611
Type I
Capture-R Ready Screen (4) HeartStart MRx Defibrillator/Monitor
Immucor Inc. Philips Medical Systems
2009-09-14 2009-09-14
2009-08-18 50618 2009-08-18 50623
Type II Type II
A) 100-105-025, 100-105-030, 100-105035 B) 100-111-020, 100-111-025, 100-111030, 100-111-035, 100/126/025, 100/126/030, 100/126/035 C) 100-141-025, 100-141-030, 100-141035 D) 100/134/030, 100/134/035 E) 100/112/030, 100/112/035 F) 100/127/025, 100/127/ 0066802, 0066812 M3535A, M3536A
A) All lots prior to Sept 2009 B) All lots prior to Sept 2009 C) All lots prior to Sept 2009 D) All lots prior to Sept 2009 E) All lots prior to Sept 2009 F) All lots prior to Sept 2009
Smiths Medical International Ltd. has become aware that certain Portex uncuffed paediatric tracheal tubes were manufactured with an internal diameter slightly smaller than specifications. There is a remote potential for a suction catheter to become lodged
K226 Serial numbers US00533518 - US00535118
Bond-1 Primer/Adhesive Stratus OCT Tomographer Vers. 6.0 Software A) Unicel DXI800 Thyroglobulin Antibody II B) Access System Thyroglobulin Antibody II C) Unicel DXI600 Thyroglobulin Antibady II Synchron CX Immuno-Protein Calibrator
Pentron Clinical Technologies, LLC Carl Zeiss Meditec Inc. Beckman Coulter Inc.
2009-09-14 2009-09-14 2009-09-14
2009-08-25 50640 2009-08-14 50625 2009-08-24 50639
N01IAB Stratus OCT A) A32898 B) A32898 C) A32898 442840
186620, 190582, 190985, 183847 Software Version 6.0.0 A) >618967 B) >618967 C) >618967 M901330 And Higher
2009-09-14
2009-08-24 50657
Type II
Unexpected positive reactivity with this lot of product. Invalid test result due to unexpected negative reactions with the positive control observed with this lot. The devices were shipped with an incorrect configuration file, disarming the 'flashing red x' and audible alarms when they are powered by AC or DC power and have no battery or low battery capacity. This also causes a weekly self diagnostic test to run hou Some of the bottles had already gelled and were unusable. A defect in Version 6.0.0 of Stratus OCT instrument and review software, in certain situations reports generated will have incorrectly labelled OD (right eye) or OS (left eye). The Access Thyroglobulin Antibody II (THGAB II) assay demonstrates increased low-end imprecision and false positive rate when run in conjunction (i.e. random access mode) with the Access Accutnl assay. The recovery of the standard has shifted. Standardizaton of the Immuno Protein Calibrator Set has been re-established to IFCC reference preparation for plasma proteins, BCD-470. This has caused a shift in quality control results and patient results for Ig
Phenobarbital And Drug Calibrator 1
2009-09-14
2009-08-28 50663
Type II
469600, 469785
Reagent part # 469785 lots M810083 and earlier, There is variability in results of Phenobarbital (PHE) Reagent and Drug Calibrator 1. Results Drug Calibrator part # 469600 lots M810440 and may vary from -3% to +17% with different reagent and calibrator lot combinations when earlier. measured against the established gas chromatography flame ionization detect Boston is sending safety alert to customers to re-emphasize the device's approved indications and remind that this product is not intended or indicated for use with glue or glue mixtures. An inconsistency was noted in the i-Stat System manuals regarding the volume of saline used to flush an indwelling line and the volume of blood to be discarded for clearing the line when testing coagulation cartridges. The rare possibility exists for a pump encoder failure to go undetected and cause a pump to spin rapidly and possibly infuse anticoagulant to a donor. This has occurred just one time in over fifteen million procedures in the past 10 years. Medtronic has determined that Sutureless Connector (SC) Intrathecal Catheters and Revision Kits are not compatible with Isomed Infusion Pumps. A physical interference between the SC Catheter Connector and the Isomed Pump prevents the SC Catheter from completely connecting to the Isomed Pump even though it may appear to be connected and feel secure. Internal testing conducted by the manufacturer has determined that Advia Centaur V. 4.0 and Advia Centaur XP V. 6.0 system software is missing range flags and no reflex testing after restoring definition files and reflex for Hepatitis B surface antigen (HBSAG) is not updated.
Spinnaker Elite Flow Directed Catheter
Boston Scientific Cork Ltd.
2009-09-28
2009-08-05 50289
Type II
549015-2, 549020-2, 549030-2, 559010- N/A 2, 559020-2, 559030-2 A) 07G81-01, 07G81-02 B) 07G01-01, 07G01-02 09000-100-E, 09000-110-EWC A) All Lots B) All Lots >10 Numbers, Contact Manufacturer
A) I-Stat Kaolin Act Cartridge B) I-Stat Act Celite Cartridge MCS+Mobile Collection System, LN 9000
Abbott Point Of Care Inc.
2009-09-28
2009-08-11 50427
Type II
Haemonetics Corporation
2009-09-28
2009-08-31 50666
Type II
Sutureless Connector Intrathecal Catheters and Revision Kits
Medtronic Inc.
2009-09-28
2009-08-27 50614
Type I
8578, 8709SC, 8731SC, 8596SC
A) Advia Centaur System Software Class 3 B) Advia Centaur XP System Software Class 2 C) Advia Centaur XP System Software Class 4 D) Advia Centaur XP System Software Class 3 E) Advia Centaur System Software Class 2 F) Advia Centaur System Software Class 4 A) PowerProMax Battery Modular Handpiece B) PowerProMax Battery 2-Trigger/Full F HP C) PowerProMax Oscilator Handpiece D) PowerProMax Reciprocator Saw Handpiece E) MPower Battery Two Trigger F) MPower Battery Sternum Saw G) MPower Battery Handpieces H) PowerPro Battery Trigger Handpiece
2009-09-28
2009-08-28 50676
Type III
2009-09-28
2009-08-14 50403
Type II
A) 04911855, 078-A001-14 B) 078-A010-07, 09066916 C) 078-A010-07, 09066916 D) 078-A010-07, 09066916 E) 04911855, 078-A001-14 F) 04911855, 078-A001-14 A) PRO5100M B) PRO5200M C) PRO5300M D) PRO5400M E) PRO6202 F) PRO6450 G) PRO6200, PRO6300, PRO6400 H) PRO5200, PRO5100, PRO5300, PRO5400 525.07
Uniglide Tibia, Cementless Size 7
Corin Limited
2009-09-28
2009-08-06 50619
Type III
A) Version 4.0 Software B) Version 6.0 Software C) Version 6.0 Software D) Version 6.0 Software E) Version 4.0 Software F) Version 4.0 Software A) BBB97037, BBB97730, BBB97731, BBB97734, BBB98124, BBB98125, BBB99622, BBB99925, BBC07409, BBC07410 B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) BBC98784, BBC98787, BBD08568 G) >100 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer NACN
The manufacturer has determined there is a remote possibility that certain handpieces may self activate.
TestOxidase Reagent Staph Xtra Latex Kit
Pro-Lab Diagnostics Pro-Lab Diagnostics
2009-09-28 2009-09-28
2009-06-30 49922 2009-06-30 49925
Type III Type II
PL.390 PL.1080, PL.1081
5824, 5884, 5971, 6038, 6136
Galileo 1000 Microliter Syringe Galileo Echo Blood Bank Analyzer
Immucor Inc. Immucor Inc.
2009-09-28 2009-09-28
2009-08-24 50713 2009-08-28 50717
Type III Type II
65051 87000
PL1080 Lot 6066, PL1080 LOT 6087, PL1080 LOT 6240, PL1081 LOT 5927, PL1081 LOT 6067, PL1081 LOT 6088, PL1081 LOT 6127, PL1081 LOT 6237, PL1081 LOT C6340, PL1081 LOT C6375 >10 Numbers, Contact Manufacturer The glue joint between the glass and the metal can be insufficient on some syringes, which, over the time, can lead to leaking and possibly to breakage of the glass barrel. N/A QC may not be reset after reported QC failure. This occurs because QC passed but was repeated and failed prior to the 24-hour expiration period established for the first QC.
Insufficient process control of the sterile barrier (blister lid) sealing process. The devices have been sealed in blister packs. Pack test results from one day's production met minimum requirements of the testing regime but there was a step change in the test results indicating a change to the validated process. The affected lot numbers of the reagent, normally clear or tan in colour, have shown a purple discolouration. Product performance is not affected. The affected lot numbers of the reagent, may display graininess that could be misinterpreted as a false positive result.
Search-Cyte Duo Reagent Red Blood Cells Immulite 2000 System-Androstenedione AS Sequencer
Biotest Medical Diagnostics GMBH Siemens Healthcare Diagnostics Products Limited Impac Medical Systems Inc.
2009-09-28 2009-09-28 2009-09-28
2009-08-24 50727 2009-09-04 50731 2009-08-27 50644
70226 L2KAO2 10-0020
169053 217 Sequencer for MOSAIQ 1.30, Sequencer for MOSAIQ 1.40, Sequencer for MOSAIQ 1.41, Sequencer for MOSAIQ 1.50, Sequencer for MOSAIQ 1.60, Sequencer for MOSAIQ 2.00 A) N/A B) N/A
A) PCR Eleva S B) PCR Compano Eleva TDX SR Power Wheelchair
Philips Medical Systems DMC GMBH
2009-09-28
2009-02-23 46769
Type II
A) PCR ELEVA S B) PCR ELEVA PLUS
Invacare Corporation
2009-09-28
2009-09-02 50704
Type II
TDXSR, TDXSR-CG, TDXSR-CG-HD, N/A TDXSR-HD, TDXSR-MCG, TDXSR-MCGHD, TDXSRV-HD
A) Aria Software B) Aria Offline Review Software Updated recall # 49074 previously posted on 200906-22. C0R36 15x100mm Kii Optical Access Sys
2009-09-28
2009-05-09 49074
Type II
A) 8.1.15, 8.5.11, 8.6.07, HIT B) 8.1.15, 8.5.11, 8.6.07, HIT
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer
Applied Medical Resources Corporation
2009-09-28
2009-06-09 50115
Type II
C0R36
1084426, 1085506, 1082348
Cell II of this product tests positive with the direct coombs test which interferes with antibody screening procedures causing false positive results. Lot numbers exhibit a positive bias with quality controls and patient results (average about +20%). The problem is a defect in the RTP Import functionality (SEQUENCER) during the import of an RTP plan, which converts the Field between coordinate systems that swap the X and Y axes (e.g., from IEC1217 to IEC601). The subject defect did not impair the accuracy of or the ability to use QA mode. Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS. On some chairs the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may exhibit a tendency to do one or more of the following: 1) veer to one side, 2) rock forward onto its front riggings, 3) drive in an unintended circular motion, and/or 4)fall forward or to one side and injure the user. An anomaly exists in the software, which leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result, potentially leading to serious injury. A cannula tip had fractured during a gastric bypass procedure. The resulting fragments were recovered and the event did not directly result in patient injury. However, the surgeon converted the laparoscopic procedure to "open" to confirm all fragments were recovered. The identity of other medical devices or accessories used in the event is unknown. The recall is initiated to provide important new safety information and patient management recommendations related to the potential for bowel obstruction and/or perforation in a small percentage of Medtronic Enterra Therapy System patients. Enterra Therapy leads may wrap around or perforate the bowel. Affected devices may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the recommended replacement time (RRT) earlier than expected. R series may display an ECG fault 7 message and fail to display the ECG baseline. Failure to display the patient's ECG could delay delivery of defibrillation or pacing therapy. Manufacturer received 21 complaints that catalyst portion of TempBond Clear with Triclosan syringes was polymerized and therefore unusable. An investigation confirmed the complaints. Siemens Healthcare Diagnostics received customer complaints regarding Immulite / Immulite 1000 total T4 kit assay where the barcode did not correspond to the kit barcode lot number. It was observed that there were a higher than expected number of false positive results with lot A090504Z and the presence of higher levels of endotoxins was found. 1. Incorrect imaging resulting from 3rd party digital image (Dicom) incompatibility. 2. Potential incorrect patient identification on report. Both may result in inaccurate or inappropriate treatment. Manufacturer is replacing these adaptors with new, more advanced product, which include surge protection hardware that will reduce the risk of breathing circuit heater wire malfunction. Measurement values provided by Seno Advantage Workstations 1x. 2.0 & 2.1 may be incorrect when applied to magnification images acquired on non-GE digital mammography systems, which could lead to overestimate of size of breast lesion. Customer complaints regarding Dimension Vista Systems connected to a Streamlab Analytical Workcell where it has been observed on rare occasions an intermittent low result. UA233, batch 154107, was incorrectly labelled with an expiry date of August 28, 2011. The correct expiry date is November 29, 2010. Stryker has identified a need to provide specific instructions for initiating power to the Calcar Planer prior to engagement with bone in the cutting edge, Omnifit HFX, Secur-Fit Max/Secur-Fit Plus Max, and Omnifit Eon Surgical Protocols, as well as to provide specific instructions for rasping dense bone and/or narrow intra medullary canals for the Accolade Surgical Protocol. There is an intermittent series of events in which a print or store event failure may cause the following to occur: A) The last image of a patient study can be stored with the next new patient study performed. B) If the first patient's last image had measurement results they will appear on the next patient's image. C) When a distance ratio or area ratio measurement is performed with L Testis Mass 2 measurement label, it appears in the report as R Testis Mass 2 in English only. D) When more than 4 measurements of the same label are performed they will not appear on-screen or on the printed report. Sterile barrier in the packaging of affected product may be compromised. Pouch seal (top seal) may be breached.
A) Unipolar Intramuscular Leads B) Enterra Gastric Stimulation Leads C) Enterra Therapy GastricC Stimulation IPG A) Virtuoso Dual Chamber ICD B) Concerto CRT-D C) Virtuoso Single Chamber ICD R Series Defibrillator/Pacemaker/Monitor
Medtronic Inc.
2009-09-28
2009-09-04 50734
Type II
A) 4300-35, 4300-50 B) 4351 C) 3116, 7425G A) D164AWG B) C174AWK C) D164VWC Zoll R Series
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer S/N AF07F001253, S/N AF08G005269, S/N AF08J005776, S/N AF08L006574, S/N AF09B006789, S/N AF09B006791 3257280, 3229807, 3268505, 3277455, 3258772, 3269811 351
Medtronic Inc.
2009-09-28
2009-09-09 50790
Type II
Zoll Medical Corporation
2009-09-28
2009-09-02 50795
Type II
TempBond Clear with Triclosan
Kerr Corporation
2009-09-28
2009-09-09 50813
Type III
33351
Immulite System-Total T4 Assay
Siemens Healthcare Diagnostics Products Ltd.
2009-09-28
2009-09-14 50818
Type III
LKT41, LKT45
Quantiferon-TB Gold In-Tube Ilumavision Software Ver. 2.1.0
Cellestis Ltd. Imtec Imaging, LLC
2009-10-12 2009-10-12
2009-09-01 50725 2009-08-03 50774
Type III Type II
N/A N/A
A090504Z Version 2.1.0
Heater Wire Adaptors
Fisher And Paykel Healthcare Ltd.
2009-10-12
2009-07-23 50850
Type II
900MR800
All Lot Numbers
A) AW Volumeshare B) AW Volumeshare2 Streamlab Analytical Workcell
2009-10-12
2009-09-15 49927
Type II
A) S30321ZK B) 5183859-3, 5183859-4, 5183859-5 Workcell
Siemens Healthcare Diagnostics Products GMBH
2009-10-12
2009-09-09 50779
Type III
A) >10 Numbers, Contact Manufacturer B) S/N'S A8177079, A9062007, 9093001, A7274009, M8281004, 8354008 N/A
Uric Acid Assay A) Calcar Planer Surgical Protocols B) Accolade Surgical Protocol
Randox Laboratories Ltd. Howmedica Osteonics Corporation
2009-10-12 2009-10-12
2009-09-15 50863 2009-09-14 50823
Type III Type II
UA233 A) LSP42, LSP46, LSP47M, LSP48 B) LASST
154107 A) N/A B) N/A
Acuson S2000
2009-10-12
2009-09-08 50793
Type II
10041461
200252, 200288, 200334, 200926, 200979, 200995
A) Renegade Fiber Braided Microcatheter B) Renegade Hi-Flow Microtainer
Boston Scientific Cork Ltd.
2009-10-12
2009-08-26 50811
Type II
A) 18-251, 18-252, 18-253 A) >100 Numbers, Contact Manufacturer B) 18-285, 18-286, 18-288, 18-289, 18B) >100 Numbers, Contact Manufacturer 290, 18-291, 18-298, 18-299, 18-300, 18302, 18-303
Renegade Fiber Braided Microcatheter Histopaque 1077-1
Boston Scientific Cork Ltd. Sigma Diagnostics
2009-10-12 2009-10-12
2009-08-26 50941 2009-09-21 50914
Type II Type III
18-257, 18-259 1077-1
>100 Numbers, Contact Manufacturer 038K6170
A) Transport Stretcher B) M-Series Stretcher C) Trauma Stretcher D) Eye Surgery Stretcher Express SD Premounted Stent System
Stryker Medical
2009-10-12
2009-08-31 50938
Type II
A) 0737-000-000, 0738-000-000 B) 1007-000-000 (SM104) C) 1027-000-000 D) 1079-000-000 H74937911515900, H74937911614900, H74937911715900, H74937912519900, H74937912618150, H74937912618900 YG18568 GTOB20042 360500
2009-10-12
2009-04-14 48011
Type III
Steris Harmony LL500/700 Surgical Light GT Obturators Hypergel 5 Gram
Steris Corporation Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics Molnlycke Health Care AB
2009-10-12 2009-10-12 2009-10-12
2009-09-14 50864 2009-09-25 50931 2009-09-22 50961
A) >10 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) 0811100540, 0812101547, 0812102798, 0901034284, 0901034285 12045170, 12070363, 12073173, 12054585, 12054587, 12054580, 12082319, 12082341, 12045167, 12085875, 12089749, 12089752, 12129028 >10 Numbers, Contact Manufacturer 12709123 08D22-156-32913, 08D22-157
Sterile barrier in the packaging of affected product may be compromised. Pouch seal (top seal) may be breached. Bacterial contamination (Pseudomonas mendocina) in the affected device.The device is a cell separation media and in the reported instance was used to isolate stem cells from bone marrow specimens. The isolated cells were placed into cell culture for further testing and contamination was evident after 14 days of culture. The laboratory confirmed the source of contamination was the device. The stretchers have the potential for the bushing in the braking system to fracture, which could result in the brake/steer pedal seizing. If the pedal seizes, the braking system may become inoperable and/or steering around corners may become more difficult.
Packaging for the applicable devices may not include a written copy of the product directions for use.
Speedlink 5.5 Transverse Connector
Zimmer Spine Austin, Inc.
2009-10-12
2009-09-22 50964
Type III
1302-55M
55QJ
A welded seam at the joint of the spring-loaded arm of the surgical light may brake and the light head may become disengaged and fall. The product, GT Obturators, GTOB20042, lot 012709123 was found to contain mixed instruments, size 20, taper .04 (20/.04) and size 20, taper .08 (20/.08) obturators. Hypergel 5 gram, product code 360500, lot numbers 08d22-156-32913 and 08d22-157, have been distributed with a lot number deficiency wherein the lot number listed on the packaging does not match the lot number on the individual piece. This action is being conducted because a small quantity of titanium alloy was discovered to have a discrepancy from the alloying process at another manufacturer. Alloy segregation can affect material strength. It has been suggested that the metal used to manufacture parts from lot 55QJ may have a similar problem, though testing has not shown this. Table locks may not actuate, causing tabletop to unexpectedly float in either the lateral axes or both the longitudinal and lateral axes, which could result in patient or operator injury.
A) Definium 8000 Digital Radiographic System B) Proteus XR/A General Purpose Radiographic C) Revolution XR/D Digital Radiographic System Synex II System - Central Body
GE Healthcare
2009-10-12
2009-09-21 47780
Type II
Synthes (Canada) Ltd.
2009-10-12
2009-09-23 50981
Type II
A) Immulite System-Reactive Protein (CRP) Assay B) Immulite 2500 System-HIH Sensit CRP Assay C) Immulite 1000 System-Cardiac HSCRP Assay D) Immulite System-Cardiac HSCRP Assay E) Immulite 2000 System-Cardiac HSCRP Assay F) Immulite 2500 System-HSCRP Assay G) Immulite 1000 System-High Sens CRP Assay H) Immulite 3000 Systems-High Sens CRP Assay I) Immulite System-High Sensitivity CRP Assay J) Immulite 1000 System-C-Reactive Protein Revolution Centrifugal Blood Pump
Siemens Healthcare Diagnostics Products Limited
2009-10-26
2009-09-11 50797
Type II
Sorin Group Italia S.R.L.
2009-10-26
2009-09-23 51015
Type II
A) 2259988-2, 5131070 B) 2259973-3, 2259976, 2259988, S3918KD/KE C) 2351505, 5131070, S3918LD 04.808.001, 04.808.002, 04.808.003, 04.808.004, 04.808.005, 04.808.006, 04.808.007, 04.808.008, 04.808.009, 04.808.010, 04.808.011 A) LCRCM B) LCRCM C) LCRCM D) LCRCM E) L2KCRP2 F) LCRCM G) LCRCM H) L2KCRP2 I) LCRCM J) LCRCM 50300700
A) >10 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer All Lot Numbers
A) 022L, 025L B) 022L, 025L C) 022L, 025L D) 022L, 025L E) 243 F) 022L, 025L G) 022L, 025L H) 243 I) 022L, 025L J) 022L, 025L 0905220164, 0906240184
Synthes (Canada), Ltd. was notified by their supplier, Synthes (USA), of six complaints reported outside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of six to fifteen months post operatively. Siemens Healthcare Diagnostics received customer complaints regarding instabilities of high sensitivity C-reactive protein adjusters and controls giving an average positive bias of 20% compared with results from previous lots.
Da Vinci S Surgical System, Model IS2000
Intuitive Surgical Inc.
2009-10-26
2009-07-01 51026
Type III
IS2000
N/A
Sarns Disposable Centrifugal Pump
Terumo Cardiovascular System Corporation
2009-10-26
2009-07-06 51040
Type II
164275
KN10, KP08, LA12, LC16, LE15
Sorin Group Italia has recently identified a weakness in the plastic packaging tray used for the Revolution Centrifugal Blood Pump that might lead the packaging tray to crack. Cracks in the packaging tray can compromise the product sterility. Intuitive Surgical Inc. observed an electronics subsystem failure that resulted in partial intermittent closure of the instrument grip (IS2000 system). A software coding error in P7 caused the error for the MTM grip. Terumo Cardiovascular Systems has received three reports of tubing disconnecting from the pump inlet of the Sarns Disposable Centrifugal Pump during cardiopulmonary bypass. 1. Moulding flash during manufacturing of T-piece at supplier caused out of specification aperture. 2. Severity in risk analysis control document (RAC) scored low leading to less strict supplier inspection and process control requirements. The Connection Bracket show too much mechanical play at the operating room table interface for some procedures. The cause of this play, is that the hole in the lock washer, which is responsible for locking the accessory to the operating room table interface, is too large. Update: The manufacturer now requests return of the affected devices. A sufficiently worn/damaged Universal Cable MC5057, used with Conmed Linvatec Electric Handpieces may cause the handpiece to self activate.
Giraffe & Panda T-Piece Resuscitation System
Ohmeda Medical, A Division Of Datex Ohmeda Inc. Maquet GMBH & Co. KG
2009-10-26
2009-09-22 51025
Type II
M1091316, M1091335, M1091365
N/A
Connection Bracket 1180.36AO
2009-10-26
2009-09-30 51053
Type II
1180.360AO
N/A
MC5057 Universal Cable Updated recall # 50401 previously posted on 2009-09-14.
2009-10-26
2009-08-14 50401
Type II
537702
N/A
A) PowerProMax Battery Modular Handpiece B) PowerProMax Battery 2-Trigger/Full F HP C) PowerProMax Oscilator Handpiece D) PowerProMax Reciprocator Saw Handpiece E) MPower Battery Two Trigger F) MPower Battery Sternum Saw G) MPower Battery Handpieces H) PowerPro Battery Trigger Handpiece Updated recall # 50403 previously posted on 2009-09-28 Impression Coping Closed Tray
2009-10-26
2009-08-14 50403
Type II
A) PRO5100M B) PRO5200M C) PRO5300M D) PRO5400M E) PRO6202 F) PRO6450 G) PRO6200, PRO6300, PRO6400 H) PRO5200, PRO5100, PRO5300, PRO5400 N/A
Nobel Biocare AB
2009-10-26
2009-05-21 48621
Type II
A) BBB97037, BBB97730, BBB97731, BBB97734, BBB98124, BBB98125, BBB99622, BBB99925, BBC07409, BBC07410 B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) BBC98784, BBC98787, BBD08568 G) >100 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer 687218
Update: The manufacturer now requests return of the affected devices. The manufacturer has determined there is a remote possibility that certain handpieces may self activate.
XTEN, HLX 3004, HLX 3005
Maquet S.A.
2009-10-26
2009-09-24 50977
Type III
ARD 567801093, ARD 567801094, ARD >10 Numbers, Contact Manufacturer 567910901, ARD 567910910 A) K7058 B) K7022 C) 10445904 D) 10445888 164275 ENGEN A) 07310MA, 08029MA, 08252MA, 08336MA B) 07311MA, 08043MA, 09077MA, 07177MA C) 07310MA, 08029MA, 08252MA, 08336MA D) 07177MA, 07311MA, 08043MA, 09077MA KN10, KP08, LA12, LC16, LE15 JCT20Q3J
A) Antistreptolysin O Assay B) Antistrepolysin O Assay C) IGM Flex Assay D) ASL Flex Reagent Sarns Disposable Centrifugal Pump Engen Automated Sample Handling System
2009-10-26
2009-09-24 50979
Type III
Nobel Biocare received several complaints from customers. After investigation it was determined that one batch of Impression Coping Closed Tray Nobelactive INT RP Q6x9mm was mis-packaged. Excessive strain may cause impairment of the interlocking between the arm joint and surgical light. Inappropriate handling may cause a crack on the front pivot of the Acrobat 2000 spring arm. Under certain conditions the software falsely elevated the results particularly if the preceding serum sample has a higher volume and concentration of beta2-microglobulin, antistrepolysin o, or immunoglobulin M analytes. Tubing disconnecting from the pump inlet of the disposable centrifugal pump during cardiopulmonary bypass. Ortho Clinical Diagnostics is aware of one confirmed report of misreported patient results with the Engen Laboratory Automation System. When used with TCAutomation software versions 2.8.2 or below, incorrect sample IDs may be electronically written to the radio frequency ID tags on the sample carriers. Five complaints involving braze joint failures of AdvanSync Telescopic Rod Assemblies resulting in a recall.
Termo Cardiovascular System Corporation Thermo Fisher Scientific OY
2009-10-26 2009-10-26
2009-07-14 51040 2009-10-06 51117
Type II Type I
AdvanSync Orthodontic Device
Ormco Corporation
2009-10-26
2009-10-05 51125
Type III
600-4000
080901333, 080902356, 070981416, 060971299, 060976084, 080902357, 080901335, 070981417, 060971304, 060976079 09187AA
Dimension Vista System-Urea Nitrogen Assay
2009-10-26
2009-09-28 51016
Type III
K1021
Received customer complaints regarding inaccurate results with the Bun Flex Reagent cartridge lots 09154AE and 09187AA.The test results may be falsely depressed or elevated. The product is labelled as 25 mm in length but the files are actually 31 mm in length. The company has become aware that there is the potential that over time, a buildup of surgical waste on the receptacle bearing surfaces may increase the force required to rotate the suction manifold. If the force becomes too high the manifold cannot be rotated therefore it cannot be inserted or removed. Once this occurs there will be no vacuum applied to the suction manifold so the primary function of the affected rover canister is lost. Amplatz PTFE-Coated Guidewires, part number 13BX, sold as lot 96158DB, may have been mis-packaged with product from lot number 96159DB. In this case, the outer box is labelled with the errant 96158DB lot number while the inner pouches are correctly labelled as lot 96159DB. Possibility of the balloon rupturing during use. Advisory letter was sent to customers of Revlite System with Revision E1 software, declaring that if PTP keypad is pressed while the wavelength window is green, the system may not complete change to new wavelength as requested. Sterile barrier in the packaging of the affected product may be compromised. It has been reported that the outer pouch seal may be breached. On some units of the Manual Pulmonary Resuscitator (MPR), the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this were to occur, the MPR may loose its ability to generate the positive pressure necessary to function properly. There is a slight possibility of outer pouch failure during shipping, which could result in the introduction of an inner pouch having non-sterile outer surfaces into the sterile field. The innermost packaging has been shown to remain intact. Proper dispensing technique must be followed, placing the product, rather than the inner pouch, into the sterile field. Cover caps exhibited visible cracks post sterilization. Testing indicates the integrity of the packaging was maintained by an inner o-ring seal. The date range of distribution for the affected products is 2007/04/26 to 2007/08/01.
Lexicon K-File Neptune 2 Ultra Rover
Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics Stryker Instruments
2009-10-26 2009-10-26
2009-09-29 51017 2009-10-06 51120
Type III Type II
KF01025 0702-001-000
811000105 >10 Numbers, Contact Manufacturer
Amplatz PTFE-Coated Guidewire
Gyrus Acmi, Inc.
2009-11-09
2009-08-25 50973
Type III
13BX
96158DB
Endoclamp Aortic Catheter Revlite
Edwards Lifesciences Hoya Conbio
2009-11-09 2009-11-09
2009-10-01 51118 2009-03-31 49248
Type II Type III
EC1001 N/A
>10 Numbers, Contact Manufacturer RL-1094
Equalizer Balloon Catheter Manual Pulmonary Resuscitator (MPR)
Boston Scientific Cork Ltd. Unomedical Inc.
2009-11-09 2009-11-09
2009-09-30 51119 2009-10-08 51151
Type II Type I
M001171060, M001171080, M001171100, M001171120 724-E
>100 Numbers, Contact Manufacturer 03-25
Bryan Cervical Disk System
Medtronic Sofamor Danek USA, Inc.
2009-11-09
2009-10-09 51184
Type II
6470114, 6470115, 6470116, 6470117, 6470118
A) Screwplant Implants B) Screwplant Healing Collars C) Legacy Healing Collars D) Screwindirect Implants E) Screwplus Implants F) Screwdirect Implants G) Replant Implants H) Replus Implants Updated recall # 50598 previously posted on 200909-14
Implant Direct LLC
2009-11-09
2009-08-18 50598
Type II
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A
A) > 100 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer C) > 10 Numbers, Contact Manufacturer D) > 10 Numbers, Contact Manufacturer E) > 10 Numbers, Contact Manufacturer F) > 10 Numbers, Contact Manufacturer G) > 10 Numbers, Contact Manufacturer H) > 10 Numbers, Contact Manufacturer
Contour SE Microspheres
2009-11-09
2009-08-28 50810
Type II
Maquet Hanaulux Model Blue 130
Maquet S.A.
2009-11-09
2009-09-22 50980
Type III
M001761101, M001761122, M001761141, M001761162, M001761201, M001761222, M001761241, M001761262, M001761301, M001761322, M001761341, M001761362, M001761401, M001761422, M001761441, M001761462, M001761501, M001761522, M001761541, M001761562 56077943
All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in the packaging (pouch) that contains the vial may be breached.
00001717, 00001719
Guider Softip Guiding Catheter
Medi-Tech Boston Scientific Corporation
2009-11-09
2009-10-07 51219
Type II
Syngo Imaging XS Syngo Imaging XS Heater Wire Adaptors Updated recall # 50850 previously posted on 200910-12. Midas Touch Needle Electrode
Siemens AG Siemens AG Fisher And Paykel Healthcare Ltd.
2009-11-09 2009-11-09 2009-11-09
2009-10-13 51220 2009-10-13 51221 2009-07-23 50850
Type III Type III N/A
10042, 10043, 10044, 10046, 10047, 10048, 10050, 10051, 10052, 10062, 10063, 10064, 10142, 10143, 10144, 10146, 10147, 10148, 10150, 10151, 10152, 10162, 10163, 10164 104 96 279 075 020 29 N/A
1225, 1532, 1533 14630 N/A
Olsen Medical
2009-11-09
2009-09-24 51204
Type II
30-1014
011668, 011970
Wallach LL 100 Cryosurgery Device Von Willebrand Reagent XIO Radiation Treatment Planning System
Cooper Surgical Inc. Also Trading As Wallach Surgical Devices Siemens Healthcare Diagnostics Products GMBH Computerized Medical Systems, Inc. (DBA CMS, Inc.) The Elekta Group Siemens Medical Solutions USA, Inc. Haag-Streit, AG
2009-11-09 2009-11-09 2009-11-09
2009-09-19 51212 2009-10-13 51218 2009-10-13 51241
REF-900000-900002, REF-900034, REF- >10 Numbers, Contact Manufacturer 900509-5 OUBD23 537675, 537682 N/A Release 4.3.0 & Higher
A) Acuson Antares Software Version 4.0 B) Acuson Antares Main Unit/5.0 Upgrades Goldmann Applanation Tonometer Prism
2009-11-09 2009-11-09
2009-10-08 51249 2009-10-13 51262
Type III Type III
A) 05936518 B) 10032746 1000855
A) 112267, 10134 B) 114573, 113469 >100 Numbers, Contact Manufacturer
Gammacoat Plasma Renin Activity 123I RIA Kit
Diasorin Inc./S.R.L.
2009-11-09
2009-10-19 51278
Type II
N/A
123574, 123612, 123620
There is potential for a crack on the front pivot of the Acrobat 2000 spring arm installed with a Blue 130 series surgical light that could cause the surgical light to swing freely. Defect rate is 0.35%. It is believed that vast swings in environmental conditions can impact catheter products over time. Improper storage may cause polymer degradation in portions of the catheter. Use of degraded catheters can expose patients to potential adverse events including a delay in procedure time due to catheter exchange, vessel trauma and stroke. Boston Scientific Corp. is issuing a safety alert reminding users to follow directions for use. A potential of a single image of a series is displayed "distorted" after loading to a viewing application. Potential loss of single image data of prior examinations when archived to network-attached storage (NAS) or hierarchical storage management (HSM). After further review it has been determined that this action by the manufacturer is not considered a recall under the definition of recall, but is considered a product withdrawal by the manufacturer. The recall was initiated due to recent tests that indicated some Midas Touch Needle Electrodes with modified tip might have an insulation breach and could generate a risk of superficial burn to the patient and/or end-user. Under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimal temperature delivery to the treatment site. An incorrect sensitivity limit has been assigned which is reagent specific and could cause results to be erroneously elevated between 17% and 40%. If an auto port is created for a beam on focal, the plan sent to XIO and the beam edited, it is possible the graphic beam representation and dose display do not agree with the edited field on the text page. Potential software problem with Acuson and Sonoline Antares systems product version 5.0 with cardiac option installed below software version 200.0.079. In Europe, Hagg-Streit received 3 reports concerning leaking Tonometer Prisms. A known reason of failing Tonometer Prisms is the use of disinfectants not approved and not released by Haag-Streit, mainly cool wipes. This might lead to irritation of cornea and in rare cases to reversible corneal erosions. The Renin Activity Control provided with the kit has an incorrect range printed on the label. Printed range on the label is 5.5 - 10.3 ng/ml/hr. The correct range is 4.0 -7.6 ng/ml/hr. To inform customers about a potential issue, when receiving the multiple PSV measurements from some ultrasound systems, the absolute value is not being used. When using combination of 2D-compound resolution imaging (CRI) and a pulsed wave Doppler single gate (PW) with steered Doppler angle, the displayed velocity scale is incorrect, which could delay treatment. This recall was initiated as the product description included the word 'captured' and this was not a 'captured' screw. This could cause intra operative confusion due to the mislabeling. The problem originated in 2007 and all internal product was corrected, however the product in the field was not corrected. Fractions delivered on the Artiste might not be recorded in Lantis and subsequently patients might be mistreated. Notifying users in Canada of updating cleaning instructions for the IW900 Series Infant Radiant Warmers. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held by Canadian customers which already cautions against using solutions containing specifically named chemicals. Design modifications were made to the Neuron Delivery Catheter in March 2009 to improve the catheter kink resistance. Penumbra initiated voluntary field removal of the original catheter design from the marketplace. When interfaced via A 9015 cable to an external data collection device, A 9004 monitor configured with CCAP 1.13 software will not communicate reliably through either channel 3 or 4. This issue only occurs when the monitor's analog output is set to external. Specific product codes and lot numbers of the Endo Femoral Aimers may have been improperly marked indicating the wrong size and part number. The actual 4mm Aimer is marked as 6mm and the actual 6mm Aimer is marked as 4mm. Packaging integrity may be compromised as a result of transportation and distribution of the products.
Syngo Dynamics C.S.A.N.-5.X,6.X,7.0 A) Voluson E8 Ultrasound System Main Unit B) Voluson E8 Expert Ultrasound System Intertan Hex Screw
Siemens Medical Solutions USA, Inc. GE Medical Systems Kretztechnik GMBH & CO OHG
2009-11-09 2009-11-09
2009-04-30 48348 2009-10-21 51227
Type III Type III
100 90 480 A) H48651PT B) H48661N 71642220
92241, 95243, 93477, 95071, 95248 A) S/N D00229 B) S/N D04842, D05589 & D50233 >10 Numbers, Contact Manufacturer
2009-11-09
2009-10-15 51245
Type III
A) Artiste Syngo RT Therapist Assist B) Artiste Syngo RT Therapist IW900 Series Infant Warmer
Siemens Medical Solutions USA, Inc. Oncology Care Systems Fisher And Paykel Healthcare Ltd.
2009-11-09 2009-11-09
2009-09-23 51246 2009-09-07 51309
Type III Type III
A) 08162807 B) 08162815 IW910, IW920, IW930, IW932, IW934, IW950, IW980, WITH SUFFIX JEU
A) 10024 B) 10040 All Infant Warmers in Canada.
070 Neuron Delivery Catheter
Penumbra Inc.
2009-11-09
2009-09-17 51330
Type II
N/A
BCI 9015 4-Channel Analog Output Cable
Smiths Medical PM, Inc.
2009-11-09
2009-10-19 51331
Type III
9015
W72407
Endo Femoral Aimers
Smith & Nephew, Inc., Endoscopy Division
2009-11-09
2009-09-22 50942
Type I
72201714, 72201716
A) TCD Drainage Catheters B) SKATER Single Step Drainage Set
PBN Medical Denmark A/S
2009-11-09
2009-09-22 51091
Type II
A) 716084020 B) 756007025, 756008025, 756010025, 756012025, 756506025, 756507025, 756508020, 756512020
For product code 72201714: (L) 50278012 For product code 72201716: (L)502780141 and (L)50278014 A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer
A) Triporteur Star 3 B) Quadriporteur Star 4 TheraScreen K-Ras Mutation Kit A) Online TDM Gentamicin for Roche/Hitachi B) Online TDM Gentamicin (GENT2) for Cobas pRK(Rabbit Kidney)
Orthofab Inc. Roche Diagnostics GMBH Roche Diagnostics GMBH
2009-11-09 2009-11-09 2009-11-09
2009-09-22 50934 2009-09-23 50937 2009-10-07 51194
A) 180-32040-22 B) 180-32000-07, 180-32000-22 5366259190 A) 03800504190 B) 04490843190 48-0600
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer DK146-01, DK149-01 A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer 480109
Lack of surface treatment on one of the gears of the transmission gearbox. The mixed standard component of the Therascreen Mutation may sporadically generate outof-range high results when tested with the control assay. The online TDM Gentamicin assays may generate falsely elevated control and patient results when used with the current lot of Preciset TDM 1 Calibrator on the Roche/Hitachi analyzers. The Rabbit Kidney Culture(pRK), which consisted of a monolayer culture of rabbit kidney cells used to grow viruses from a patient specimen in order to detect or identify the virus, appeared to also contain another type of cells. Ethicon is conducting a voluntary product recall of all lots of Gynecare Morcellex Tissue Morcellator due to the potential for the duckbill seal to become dislodged, and a confirmed event in which the seal was retained in a patient. Notifying users in Canada of an updated test procedure for the power-fail alarm of the IW900 Series Infant Radiant Warmer. The service manual already includes a requirement for an annual check of the power-fail alarm. The test procedure has been revised to check that the power-fail alarm operates for at least 12 minutes. The revised test procedure accounts for any unexpected degradation over time of the supercapacitor that operates the power-fail alarm. Results passed on integrating lab systems may be erroneous when using competitive tests, if they are located outside of the standard range. The Revision "H" software calculated esophageal amplitudes incorrectly when the user generated a report. There were no issues with the acquisition of the data. Users could still acquire data, however there was a requirement to install the revision 'I' software upgrade before reports were printed to ensure data was reported (printed) correctly. Lane 23 in the 'A' high resolution SSP Unitray, lot and batch number identified, will produce a false positive band at the correct base pair size in the presence of A*0301 samples. This will affect typing results on samples that are Aa*0301 homozygote, since they could be erroneously reported as A*0301/A*1101. Smith & Nephew was made aware that all parts were missing the laser etching as identification information. This action is being conducted because the part number on the locking plate (Zimmer Periarticular Locking Plate System distal lateral tibial plate) is incorrect. The part was etched as '2357-09-07', when it should have been etched '2357-09-06'. Specific lots of PDS II (polydioxanone) Absorbable Sutures are being recalled because some of these products may have a small void in the foil outer package. The void in the foil may lead to suture degradation and the potential for a compromise in the sterility of the product. Advanced Sterilization Products (ASP) is sending a letter to all Automated Endoscope Reprocessor (AER) customers to reinforce the importance of properly setting the disinfectant cycle time when using the ASP AER and to remind users to observe the illuminated temperature light during the cycle. ASP has received user reports about improper times set for each disinfectant cycle. Operator's manual does not warn against the unintended use of Apexpro Telemetry to monitor SPO2 without concurrent ECG monitoring and does not identify correct alarms and messages during loss of SPO2 data condition. The threaded connector of the battery clip housing can become loose from the battery clip housing thereby creating a potential to interrupt pump function. The Reflex Hybrid Screw Extractor Inner Shaft was reported to fail at the threaded tip and fracture in the head of the screw. There had been reports of the threaded tip of the inner shaft being left in the screw due to the surgeon being unable to remove the screw. There had also been reports of damage to the screw and/or the plate while attempting to remove the screw. The protective coating around certain electrical wires inside the Trinest Incubator/Shaker may be worn out due to contact with a round aluminum part rotating during the continuous shaking movement, which would result in a warning message and the instrument would shut down. Some of the needles may exhibit an exposed sample chamber due to extended stylet length from a loose hub connection, resulting in an inability to obtain the biopsy sample. Potential limit switch failure could occur due to collision between lateral plane of Innova positioner and other equipment, which may break x-ray and positioning switches and may not allow exam completion. Medtronic has initiated a field action to notify managing and implanting physicians of Medtronic per cutaneous leads for spinal cord stimulation of the potential for separation of the titanium insert from the silicone portion of the Titan Anchor, model 3550-39. If this occurs it may result in lead migration and compromised therapy for the patient. This action is being conducted because packages from the identified lot should contain style 5 (trocar-style three point) Steinmann pins. However, they actually contain style 6 (spadetype diamond point). The mixed standard component of the Therascreen Mutation Kit may sporadically generate out-of-range high results when tested with the control assay.
Diagnostic Hybrids, Inc.
2009-11-09
2009-01-21 51217
Type III
Gynecare Morcellex Tissue Morcellator
Ethicon Inc. Also Trading As Ethicon Women's Health And Urology Fisher And Paykel Healthcare Ltd.
2009-11-09
2009-10-09 51327
Type II
MX0100
IW900 Series Infant Warmer
2009-11-09
2009-09-07 51383
Type III
Series With Suffix > IW910, IW920, IW930, IW932, IW934, IW950, IW980
All Infant Warmers in Canada.
Systeme PhD EIA/IFA (cat# 426-0246) Insight Software Revision H,Bioview REV5.5.1
Bio-Rad Laboratories Diagnostics Group Sandhill Scientific Inc.
2009-11-09 2009-11-23
2009-10-13 51252 2009-02-23 47672
Type III Type III
4226-0228, 426-0246 S98-1925-2H
N/A All lots are affected
A Locus High Resolution SSP Unitray
Invitrogen Corporation
2009-11-23
2009-07-24 51366
Type III
47290-10, 47291-10
1145687
Recon Plate 8 X 9mm, 3.5mm Periarticular Locking Plate System
Smith & Nephew, Inc. Zimmer Inc.
2009-11-23 2009-11-23
2009-10-14 51369 2009-10-20 51408
Type III Type III
7114-0108 00-2357-009-06
L06MT04447, L08ET19936 60594607
A) PDS II Absorbable Sutures B) Coated Vicryl Absorbable Sutures
Ethicon Inc.
2009-11-23
2009-10-26 51428
Type II
A) Z316H B) J318H
A) ACM008 B) ACM473
ASP Automatic Endoscope Reprocessor
Advanced Sterilization Products, A Division Of Ethicon
2009-11-23
2009-09-28 51459
Type III
20300, 20301
Apexpro Telemetry System - Clinical Info.
GE Medical Systems Information Technologies
2009-11-23
2009-10-26 48250
Type II
Heartmate XVE And II LVAS Battery Clip Reflex Hybrid Screw Extractor Inner Shaft
Thoratec Corporation Stryker Spine SAS
2009-11-23 2009-11-23
2009-10-14 51438 2009-10-13 51370
Type II Type II
418779-010, APRSRVR16=XXX, CICV3APRO=XXX, CICV3APRO=XXX/XXX , CICV4APRO=XXX N/A 48511905B, 48511905D
>100 Numbers, Contact Manufacturer All lots
Trinest Microplate Incubator And Shaker
Wallac OY
2009-11-23
2009-10-21 51375
Type II
1296-0050
12960024, 12960028
Bard Magnum Core Tissue Biopsy Needle Innova 2121IQ Bi-Plane Cardio Imaging
Bard Peripheral Vascular, Inc. GE Medical Systems SCS
2009-11-23 2009-11-23
2009-10-16 51391 2009-10-30 51374
Type II Type II
MN1610, MN1613, MN1616, MN1620 S18821AM
>10 Numbers, Contact Manufacturer S/N 553918BU4
Titan Anchor Accessory Kits
Medtronic Inc.
2009-11-23
2009-10-27 51434
Type II
3550-39
Steinmann Pin
Zimmer Inc.
2009-11-23
2009-10-23 51411
Type III
18700259
61211489
Therascreen K-Ras Mutation Kit
DXS Ltd.
2009-11-23
2009-09-23 50937
Type III
KR-41
DK146-01, DK149-01
A-Dec Decade Plus 1221 Dental Chair
A-Dec, Inc.
2009-11-23
2009-04-06 51399
Type III
1221
When the chair back was returned up to the 'patient entry / exit' position, a pinch existed between the moving chair back support and the stationary underside of the armrest. There is evidence of potential microbial contamination in some vials of complement control cells (lot # 32616), based on gram stain results. Synthes (Canada), Ltd. was notified by their supplier, Synthes (USA), of six complaints reported outside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of six to fifteen months post operatively. The manufacturer has determined there is a remote possibility that the device may self activate. Zimmer Dental has received field complaints reporting that during application of torque to the abutment, the upper portion of the abutment had fractured and separated from the lower shaft. The investigation has determined that the product is not manufactured to specification. The pilot broach for threading the internal threads of the implant is too deep and extends into the shaft of the screw. Some humidifiers may fail to operate due to potential malfunction of the internal connection between the heated plate and the printed circuit board which results in a 'blinking blue light' on the humidifier control knob. If Dicom node config. is set to accept, user may unintentionally add new images to an approved exam, under certain conditions images will be deleted from PACS or from dictated, transcribed or completed status exam. A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) and error 342 (Deviation in absolute position value DSE - RDC) were displayed. Recalls 50114 and 50252 are identical. For future reference, refer to recall 50252. Customers were erroneously provided with version 0719H0166 of the operator's manual instead of the correct version 0719I0166. Excessive heating of the tip of the fixation screws with the standard non-insulated posts may cause minor burning of the contact point of patients during certain higher energy MRI usage. This action is being conducted because these components are labelled with a 10 year expiry period when in fact these components expire 5 years after manufacture. Expiration dating refers to 'use by' dates. There is no risk to patients who receive these implants prior to January 2010, when devices from the affected lots begin to expire.
Complement Control Cells Synex II System - Central Body Updated recall # 50981 previously posted on 200910-12. Advantage, 2-Button Turbo Handpiece Advent 4.5mmd Platform Tapered Abutment
Immucor Inc. Synthes (Canada) Ltd.
2009-11-23 2009-11-23
2009-10-26 51502 2009-09-23 50981
Type III Type I
N/A 04.808.001, 04.808.002, 04.808.003, 04.808.004, 04.808.005, 04.808.006, 04.808.007, 04.808.008, 04.808.009, 04.808.010, 04.808.011 D9924 AVACT
32616 All lots
Linvatec Corporation D.B.A. Conmed Linvatec Zimmer Dental Inc.
2009-12-07 2009-12-07
2009-11-09 51507 2009-11-06 51588
Type II Type II
>10 Numbers, Contact Manufacturer 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067, 61341224
Remstar M Series Heated Humidifier
Respironics Inc.
2009-12-07
2009-11-20 50202
Type II
1049109, 1049110, 1049124, 10499110, >10 Numbers, Contact Manufacturer 1051157, 1051158, R1049109, R1049110, U1049109, U1049110 K2020YS, K2030JN >100 Numbers, Contact Manufacturer
Centricity PACS Workstation - Software
GE Healthcare IT
2009-12-07
2009-10-30 51228
Type II
CyberKnife Robotic Radiosurgery System Updated recall # 50252 previously posted on 200908-31.
Accuray, Inc.
2009-12-07
2009-06-22 50252
Type II
28000
C202
Colleague Volumetric Infusion Pumps Updated recall # 44735 previously posted on 200811-24. Leksell Stereotactic System - Fixation Post
2009-12-07
2008-11-24 44735
Type III
2M9163
Elekta Instruments AB
2009-12-07
2009-10-02 51522
Type II
1003935, 1003937
N/A
A) Nexgen Rotating Hinge Knee - Femoral B) Nexgen Rotating Hinge Knee - Tibial C) Nexgen Rotating Hinge Knee,Tibial Plate D) Nexgen Rotating Hinge Knee - Femoral, B
Zimmer Inc.
2009-12-07
2009-11-06 51622
Type III
A) 00-5880-013-01, 00-5880-014-01, 005880-014-02, 00-5880-015-01, 00-5880015-02, 00-5880-016-01, 00-5880-016-02 B) 00-5880-002-00, 00-5880-003-00, 005880-004-00, 00-5880-005-00, 00-5880006-00 C) 00-5880-001-02 D) 00-5880-012-01 RED-700A
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) 60433397, 60461749 D) 60186249 H5
RET-Search II
Sysmex Reagents America
2009-12-07
2009-11-03 51623
Type II
ZY9021
Durom Acetabular Cup
Zimmer GMBH
2009-12-07
2009-11-15 51631
Type II
A) Therakair Visio B) InfoV.A.C. Therapy Unit C) First Step All in One D) ActiV.A.C. Therapy Unit E) First Step Select - Pump F) Kinair IV G) V.A.C. ATS Therapy Unit H) Proficare Pump Unit I) Therapulse ATP Staphytect Plus/Dryspot, Test Kits
KCI USA, Inc.
2009-12-07
2009-11-09 51634
Type II
Remel Europe Ltd.
2009-12-07
2009-07-09 50862
Type II
01.00214.044, 01.00214.046, 01.00214.048, 01.00214.050, 01.00214.052, 01.00214.054, 01.00214.056, 01.00214.058, 01.00214.060, 01.00214.062, 01.00214.064, 01.00214.066 A) M6257763 B) M8260027 C) 227500 D) 340013 E) 215200 F) 216050 G) M8259994 H) M8259988 I) 227080.S, 227800 DR0100M, DR0850M
Several boxes of RET-Search II (Red-700A) manufactured on July 15, 2009 had an incorrect bar code label applied to the product box. The bar code label identified the product as stromatolyser-NR with the same lot number and expiration date. The box contains a reagent bottle and dye pouch, both of which were correctly labelled, and the contents of the bottle and dye pouch are of the proper chemical composition for RET-Search II and passed all in-process and final inspection test criteria. There have been reports of revisions of Zimmer's Durom Acetabular Cup and the Metasul LDH (large diameter head) femoral head in certain European markets. Based on Zimmer's investigation, the most probable cause is using a surgical technique which differs from that prescribed in the surgical technique for the Durom Acetabular Cup. This field safety notice updates surgical technique instructions. Power cords may crack and fail leading to potential risks of electrical shock, delay in setup and therapy, interruption of therapy and fires which may also occur in an oxygen-rich environment.
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A J577910, J055610, J539110, J610610
A potential for false positive reactions with some non staphylococcus aureus strains.
A) Accura Breast Localisation Needles B) Hawkins II Breast Localisation Needles C) Hawkins I Breast Localization Needles D) Homer Mammalok Breast Localisation Needles E) Manan Co-Axial Introducer Needles F) Manan Introducer Sheath Needles G) Manan Guidewire Introducer Needles H) Manan Seldinger Needles I) Manan Modified Potts/Cournand Needles J) Manan Galactography Trays K) Skater-Centesis Catheter L) Chiba Style Manual M) Franseen Style N) Green Style O) Spinal Style P) Westcott Style Q) Hawkins III Breast Localization Needles R) Pro-Mag Disposable Biopsy Needles S) Maxi-Cell Biopsy Needles T) Ultracore Disposable Biopsy Needles U) Lorad Needle Guide neoBLUE mini LED Phototherapy System
Medical Device Technologies, Inc. DBA Angiotech
2009-12-07
2009-09-01 50935
Type II
Natus Medical Inc.
2009-12-07
2009-10-01 51237
Type II
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A J) N/A K) N/A L) N/A M) N/A N) N/A O) N/A P) N/A Q) N/A R) N/A S) N/A T) N/A U) N/A 10101
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) >10 Numbers, Contact Manufacturer G) >10 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer I) >10 Numbers, Contact Manufacturer J) >10 Numbers, Contact Manufacturer K) >10 Numbers, Contact Manufacturer L) >10 Numbers, Contact Manufacturer M) >10 Numbers, Contact Manufacturer N) >10 Numbers, Contact Manufacturer O) >10 Numbers, Contact Manufacturer P) >10 Numbers, Contact Manufacturer Q) >10 Numbers, Contact Manufacturer R) >10 Numbers, Contact Manufacturer S) >10 Numbers, Contact Manufacturer T) >10 Numbers, Contact Manufacturer U) >10 Numbers, Contact Manufacturer 60001-62656 serial number
The complaints were reported as "run off" (non-contiguous) seals. A run off seal is a seal in which the Angiotech applied seal is mis-aligned.
A) Unicel DXI600 Access Immunoassay System Class Beckman Coulter Inc. 2 B) Unicel DXI600 Access Immunoassay System Class 3 C) Unicel DXC880I Access Clinical Analyzer D) Unicel DXI800 Access Analyzer Class 3 E) Unicel DXI800 Access System Analyzer Class 2 F) Unicel DXC660I Access Clinical Analyzer G) Unicel DXC680I Access Clinical Analyzer H) Unicel DXC860I Access Clinical Analyzer Dupaque X-Ray Detectable Sponges Derma Sciences, Inc. A) Artiste MV-Syngo RT Therapist Assist B) Artiste MV-Syngo RT Therapist Siemens Medical Solutions USA, Inc. Oncology Care Systems
2009-12-07
2009-10-26 51422
Type II
A) A30260, A71461 B) A71461 C) 4768 D) 973100, A71457 E) 973100, A71457 F) 4771 G) 4772 H) 4773
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A
There has been a trend observed in failure of the pole mount clamp shipped with a neoBlue mini LED Phototherapy Systems. When tightened with excessive force, some of these clamps have shown stress fractures or broken. The pole mount clamp has been redesigned by the manufacturer and customers of record are being advised to inspect their systems and to order a replacement clamp if necessary. A software issue was identified in system software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red 'warning' event and stopping sample processing, the system will post a yellow 'caution' event and continue to operate with the dispense plate in an elevated position until the instrument is reinitialized. Potentially affected results are not flagged.
2009-12-07 2009-12-07
2009-10-27 51464 2009-11-05 51605
Type II Type III
94675-5 A) 08162807 B) 08162815
4408 A) 10024 B) 10040
Medical Grade Flat Panel Display
Spacelabs Medical, Inc.
2009-12-07
2009-10-30 51662
Type II
94260-19
Vertical Surgical Table
Stryker Communications
2009-12-07
2009-11-06 51664
Type II
0788-100-000, 0788-100-001, 0788-100- All Lot Numbers 0015 3010A, 3500-306, 3500-415, 3500-500 >100 Numbers, Contact Manufacturer
Medfusion Syringe Infusion Pumps
2009-12-07
2009-11-16 51668
Type II
Received two complaints from a customer indicating that the sponge separated at the end during surgery and was left behind. Two or more treatment plans with different ISOcenter positions are stored together in one course in Lantis, e.g. main treatment plan and boost plan. If the cone beam is acquired using calculation of table shift coordinates will be based on ISOcenter position. This will lead to an incorrect table shift. A potential safety hazard associated with the use of Spacelabs Medical 19" Flat Panel Displays, model 94260-19. There is a possibility that the internal power distribution circuit board will fail prematurely, causing the display to go blank. Audio alarms will continue to function normally. The table may experience involuntary movement as a result of fluid intrusion. This hazard can arise especially when the table is in the trendelenburg or anti-trendelenburg position allowing fluids, such as saline or water, to enter the table column. Smiths Medical has become aware of an increased trend in reports of "motor not running" ("MNR") and "motor rate error" ("MRE") alarm message events with certain Medfusion Syringe Infusion Pumps, models 3010a and 3500 ("pump"). These are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of these pumps. The pump stops delivery when an MNR/MRE alarm message event occurs. Bioplex 2200 vasculitis reagent kits could produce false results when analyzing diluted samples. RTD temperature sensor component was failing prematurely. Temperature control of the sterilization process is maintained through the use of the sensor used in the sterilizer jacket and chamber. When incorrectly used the frame adapter may become damaged which in worst case could make it possible to lock the adapter so it does not properly fixate the frame. Stryker Endoscopy was aware that the SDC HD picture/video capture device would not be able to assign the correct time/date stamp for saved files after December 31st 2009. On January 1st 2010, the system date for all SDC HD units would re-start from October 1st 2001 and begin incrementing from that point onwards. This event would not affect how pictures or videos were captured using SDC HD during surgery, however the system date would be incorrect and users would not be able to correct this issue without a software upgrade. The response of the two highest points of the kit's calibration curve are the same and consequently very high D dimer values may be underestimated.
Bioflex 2200- 665-1850 Vasculitis Kit Getinge Steam Sterilizer
Bio-Rad Laboratories Diagnostics Group Getinge Sourcing LLC.
2009-12-07 2009-12-07
2009-11-06 51677 2009-09-01 50976
Type II Type II
6651850
950759, 959261, 961363
422HC, 433HC, 522HC, 533HC, 633HC, >10 Numbers, Contact Manufacturer 733HC, 833HC 715000 A) 240-050-888 B) 240-050-890 Serial Number 6005 A) All Lot Numbers B) All Lot Numbers
Leksell gamma Knife Perfexion A) SDC HD Capture Recorder B) SDC HD Capture Device
Elekta Instruments AB Stryker Endoscopy
2009-12-07 2009-12-07
2009-08-18 51437 2009-10-30 51583
Type II Type II
Auto D Dimer Kit CRS 126B
Trinity Biotech PLC
2009-12-07
2009-08-19 51650
Type II
CRS126-B
T065095, T082003, T119007
Removable Magnet Hires 90K
Advanced Bionics, LLC
2009-12-07
2009-08-25 51652
Type II
N/A
N/A
BHR Streamline Cup Introducers
2009-12-07
2009-11-11 51665
Type II
90128285
S811270
A) Intravenous Infusion Accessory IVMED20 B) Intravenous Infusion Accessory IVMED60 A) Access Immunoassay System - Troponin B) Unicel DXI600 Access Immunoassay System C) Unicel DXI800 Access Immunoassay System Triniclot PT Excel, T1106 Galileo Echo Blood Bank Analyzer
Medxl Inc. Beckman Coulter Inc.
2009-12-07 2009-12-07
2009-11-06 51696 2009-10-23 51585
Type II Type III
Trinity Biotech PLC Immucor Inc.
2009-12-07 2009-12-07
2009-08-06 51651 2009-11-06 51706
Type III Type I
A) N/A B) N/A A) A78803 B) A78803 C) A78803 T1106 87000
A) N/A B) N/A A) 915417 B) 915417 C) 915417 S172057 N/A
Galileo Echo Blood Bank Analyzer Oxidase Touch Sticks Kryptonite Bone Cement
Immucor Inc. Oxoid Limited Doctors Research Group Inc.
2009-12-07 2009-12-07 2009-12-07
2009-11-06 51708 2009-07-07 51737 2009-09-17 51492
Type I Type II Type III
87000 BR0064A KRYP-X-03, KRYP-X-10, KRYP-Z-03, KRYP-Z-10 A) M3000LF B) M3335JK C) M3335PB D) M7000BF E) M3000TD F) 2294302 G) M3333TA H) SIGNA HDXT 1.5T MR SYSTEM
N/A 702079 05072009, 05272009, 06292009, 03102009, 07142008, 10232008, 10272008, 10312008, 10282009 A) HDMR10368, 7547YR3, 278606MR9, 266072MR8, 274168MR4, 270572MR1 B) 7555YR6 C) >10 Numbers, Contact Manufacturer D) 291192MR3, 290992MR7 E) >10 Numbers, Contact Manufacturer F) 243409MR0, 239046MR6, 253630MR8, 239043MR3, 256216MR3, 246610MR0, 258415MR9, 247728MR9, 242181MR6 G) 6690YR2, 266690MR7 H) 30BD4960 HDMR2675, 9948YR1,10833YR2, 11827YR3, 8704YR9, 10685YR6, 7964YR0, 10023YR0 >10 Numbers, Contact Manufacturer A) Cup Lot Numbers Starting With "09" Or Later B) Cup Lot Numbers Starting With "09" Or Later C) Cup Lot Numbers Starting With "09" Or Later D) Cup Lot Numbers Starting With "09" Or Later E) Cup Lot Numbers Starting With "09" Or Later
A) Signa 1.5T Excite HD - Gradients B) 3.0T Signa HDX MR System - Main Unit C) 1.5T Signa HDX MR System - Hardware D) Discovery MR750 MR System - Main Unit E) 1.5T Signa Infinity Twinspeed Excite F) Signa 1.5T Infinity Excite MR System G) Signa Excite 3.0T Electronics H) Signa HDXT 1.5T MR System - Main Unit
GE Medical Systems LLC
2009-12-07
2009-11-05 50777
Type II
Advanced Bionics (AB) is notifying all surgeons, clinicians and patients that the removable magnet component of the HiRes 90k cochlear implant (model no. CI-1400-01 and CI-140002H) is susceptible to corrosion. The affected units should be monitored and replaced if necessary. The identified lot number may mechanically seize up, preventing release of the cable tightening mechanism, during surgery or before use. As a result, this could prolong surgery time. Also, if implanted, this could cause a possibility of malpositioning of the cup due to use of the device in a mechanically seized condition. A warning letter was sent to the distributor requesting that sales be suspended until a licence has been obtained. The reagents in wells three (RLC) and four (RLD) of the reagent pack were inadvertently switched during manufacturing. Lot number 915417 contains reagent RLD in well three and RLC in well four. Quality control materials not recovering within predefined ranges. Prothrombin times are prolonged in lot S172057 by about 1.2 seconds. Two lot numbers of reagents or strips are allowed to be tested while performing QC testing on the echo. The result is that the final lot tested will pass QC even though it did not undergo complete QC testing. Under some circumstances, a manually entered sample ID could be assigned to the wrong sample. May produce weak positive or false negative results. As a result of increased viscosity of component "A" in some Kryptonite Bone Cement Kits, the end user may observe difficulty in discharging component "A" from the syringe that it is packaged in. Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to present colour overlays equivalent to nonpure studies.
Signa HDE 1.5T MRI System - Magnet
GE Healthcare Japan Corporation
2009-12-07
2009-11-05 51766
Type II
M3335SE
Dimension V-Lyte Integrated Multisensor A) Unicel DXC600I Synch.Acc.Clin. Analyzer B) Unicel DXC880I Synch.Acc.Clin. Analyzer C) Unicel DXC660I Synch.Acc.Clin. Analyzer D) Unicel DXC680I Synch.Acc.Clin. Analyzer E) Unicel DXC860I Synch.Acc.Clin. Analyzer
Siemens Healthcare Diagnostics Inc. Beckman Coulter, Inc.
2009-12-07 2009-12-07
2009-10-29 51421 2009-10-22 51584
Type III Type III
K800, K820, K825, K835 A) 4767 B) 4768 C) 4771 D) 4772 E) 4773
Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to present colour overlays equivalent to nonpure studies. Received customer complaints regarding Dimension Vista V-Lyte. Siemens confirms that urine sodium results become elevated as urine specimens are run on a sensor. The access 1.0 ml insert cup, used on Unicel DXC Synchron Clinical Systems, might be the cause of some sample wheel motion errors when run using 13x100 sample tubes.
Buretrol IV Solution Adm.Sets Clearlink Power Cord Component Of Sesmoid Plasty
Baxter Healthcare Corporation Zimmer CAS
2009-12-07 2009-12-07
2009-11-05 51663 2009-11-05 51683
Type II Type II
2C8864 500.923 SUB COMP 200.301
UR09E21238
SP-122, SP-197
CBC II Blood Conservation Kit
Stryker Instruments
2009-12-07
2009-11-13 51764
Type II
225-414-000
Kyphx HV-R Bone Cement
Medtronic Spine LLC
2009-12-07
2009-11-09 51643
Type II
C01A, C01B
Model 7600 - Oximeter Pod
Nonin Medical Inc.
2009-12-07
2009-10-23 51731
Type II
Model 7600
Separation of tubing from Distal Clearlink Y-site could occur, which may result in blood loss, infection, interruption of or delay in the start of intravenous therapy. 1. Female receptacle end: the terminal contact are not sufficiently recessed and protected from access. 2. The cable portion is not certified North America. 3. The male plug that plug to the power supply mains is missing a label. >10 Numbers, Contact Manufacturer There is a potential that the package pouch in the CBC II Blood Conservation Kits may have a pin hole, a weakened seal, or an opened seal that could result in the product not being sterile. >10 Numbers, Contact Manufacturer Medtronic Spine LLC is recalling specific lots of Kyphx HV-R bone cement following complaints regarding extended time to reach the proper viscosity (doughy state) and inconsistency or lack of homogeneity during cement preparation, as well as when waiting to deliver the bone cement with the delivery device (e.g. bone filler device). 500849356, 500849358, 500849360, A malfunction with one of the components that may result in the overheating of the 500549361, 500823174, 500857064, 500874926 Oximeter pod has the potential to cause a burn if the pod is in direct contact with the patient. A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer >10 Numbers, Contact Manufacturer SRS treatments occurred with conical collimator accessory not inserted, or with conical collimator accessory correctly mounted, but with a primary collimator field size setting exceeding outside diameter of that conical collimator. With wrong field size, unintended radiation is given to patient outside the outer edge of cone. Malfunction when adding CBCT image. Present software has ability to acquire gantry angle when 'treatment approval enforced' and/or 'allow only couch parameter (vert, long, lat) editing & acquiring for approved plans' selected in treatment administration. Therapists can acquire gantry angle into plan, even without system rights to acquire gantry angle. Patient treated with wrong gantry angles one day.
A) C-Series Clinac, Trilogy & Novalis Tx B) Trilogy Radiotherapy Delivery System C) Novalis TX Linear Accelerator Varis 4D Integrated Treatment Console
2009-12-07
2009-10-08 51773
Type II
A) H18, H27, H29 B) H14, H29 C) H14, H29 8.0.12, 8.0.23 SP2 , 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0, H51
2009-12-07
2009-10-16 51774
Type II
A) BD Q-Syte Extension Set B) MPS Acadia Extension Set With Rightbore C) MPS Acadia Specialty Tri-Extension Set Tg Gen.2 (Thyroglobulin) Assay
Becton Dickinson Infusion Therapy Systems Inc.
2009-12-07
2009-11-02 51661
Type I
Roche Diagnostics GMBH
2009-12-07
2009-11-12 51712
Type II
A) 385102 B) 385150, 385151 C) 385164 5118921190
A) 8308330 B) A1967, A2399 C) A1951 155166
Duralite Pyramid Receiver Prox. Adaptor Sequencer For Mosaiq
The Ohio Willow Wood Company Impac Medical Systems Inc.
2009-12-07 2009-12-07
2009-11-09 51740 2009-10-16 51821
Type II Type II
N/A N/A
Triniclot APPT S, Cat. No. T1202
Trinity Biotech PLC
2009-12-21
2009-04-23 49895
Type II
T1202
Triniclot APTT HS, Product Code T1204 A) Imager II Angiographic Catheters B) Imager II Catheters BERN C) Imager II Catheters SIM D) Imager II Catheters Contra2 E) Imager II Catheters C F) Imager II Catheters RC G) Imager II Catheters RDC H) Imager II Catheters Pigtail I) Imager II Catheters Contralateral
Trinity Biotech PLC Boston Scientific Corporation
2009-12-21 2009-12-21
2009-05-24 49896 2009-11-03 51535
Type II Type II
T1204 A) 31-400, 31-402, 31-510, 31-516, 31520, 31-602 B) 31-407, 31-408, 31-409, 31-410, 31607, 31-609 C) 31-430, 31-631 D) 31-458, 31-459, 31-658 E) 31-466, 31-467, 31-468, 31-469, 31669 F) 31-485, 31-486, 31-685 G) 31-488, 31-489, 31-491 H) 31-509, 31-513, 31-519 I) 31-525, 31-528, 31-531 M0064003031
All Lot Numbers Mosaiq 1.40 (All Builds), Mosaiq 1.41 (All Builds), Mosaiq 1.50 (All Builds), 1.60 (Up To, Including T2SP4), 2.00 (All Builds) S067009 Precision and open vial stability issues with this lot may result in increased or decreased APTT times across the range of the assay. The lot is not stable for the full 30 day period when opened and stored. Precision issues with this lot may result in increased APTT times across the range of the R324001 assay. The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The A) >10 Numbers, Contact Manufacturer breach of sterility could lead to a contamination of the device with subsequent transfer of B) >10 Numbers, Contact Manufacturer infectious agents to the patient. C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) >10 Numbers, Contact Manufacturer G) >10 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer I) >10 Numbers, Contact Manufacturer
Product may function improperly. This may result in the risk of air bubbles leaking into the infusion system through the BD Q-Syte Luer access split septum. This may lead to complications should the air bubbles not be detected. The current lot #155166 of TG Gen.2 (Thyroglobulin) Assay shows a premature ageing effect which leads to a positive bias of approximately 1ng/ml TG when used in combination with all current lots # 151605, 152737, 155488 and 157297 of elecsys thyroglobulin calibrator. The manufacturer has determined that customers should not use it for this purpose anymore. There is a potential for the adapter to crack or break while in use by active amputees. Consolidated field sequencing (CFS) feature not working properly as X2 jaw moved when only the X1 jaw should have been moving.
Imager II Urology Torque Catheters
2009-12-21
2009-11-03 51536
Type II
Washer Disinfectors Pronto-Short Extraction Catheter
Getinge Disinfection AB Vascular Solutions, Inc.
2009-12-21 2009-12-21
2009-04-23 51707 2009-11-20 51819
Type II Type II
9027, 9100, 9120, 9125, 9128 N/A
Koordinat M/MP
Siemens AG
2009-12-21
2009-08-13 50747
Type III
05294003, 06239003
Vitrax II (Sodium Hyaluronate)
Advanced Medical Optics, Inc.
2009-12-21
2009-11-06 51828
Type II
VT465
TECNIS 1-Piece Posterior Chamber IOL
Advanced Medical Optics, Inc.
2009-12-21
2009-11-10 51829
Type II
ZCB00
A) Powerhart G3 Automated External Defibrillator B) Powerhart AED G3 Pro C) Powerhart AED G3 Plus D) Powerhart G3 Plus Automatic E) Powerhart - AED G3 (Biphasic) A) Tegaderm Hydrocolloid Dressing B) Medipore Soft Cloth Surgical Tape EZManager Max Diabetes Management Software
Cardiac Science Corporation
2009-12-21
2009-10-08 51818
Type II
3M Health Care
2009-12-21
2009-11-23 51873
Type III
A) 9300A-501PPC B) 9300P-601 C) 9390E-501 D) 9390A-501 E) 9300E-501 A) 90002 B) 2961 100-467-23, 100-467-50
Animas Corporation
2009-12-21
2009-11-16 51762
Type III
OneTouch SureStep Test Strips A) Navigation Software Knee Zimmer B) Brainlab Knee Essential Software C) Brainlab Knee Unlimited Software Dimension Vista System-Chem Calibrators
Lifescan Inc. Brainlab AG
2009-12-21 2009-12-21
2009-09-24 51926 2009-09-11 50954
Type III Type III
Part # 010-665 A) 22086-03D, 22086-03E B) 21100-01(2.0), 21100-01C(2.1) C) 70001A, 70002A(2.1) KC130
2009-12-21
2009-10-19 51373
Type III
Siregraph CF MRSASelect Referance 63747 Coffret 20 Plaque
Siemens AG Bio-Rad
2009-12-21 2009-12-21
2009-10-08 51376 2009-10-23 51525
Type III Type II
04 98 717 63747
The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient. >10 Numbers, Contact Manufacturer The ground wire of the supply transformer exhibited signs of high resistance in a complaint and may give high eddy currents. Lot 544202, Exp. 11-2009, Lot 545693, Exp. 05- The expiration date of the sterile pouched guidewire was not considered when expiration 2010, Lot 546614, Exp. 09-2010 dating was calculated for the finished device. Cannot assure sterility or function of the guidewire beyond its expiration date. >10 Numbers, Contact Manufacturer If the swivel locking mechanism is not completely engaged into position, during patient transfer, the table may unintentionally swivel, could result in uncontrolled patient movement during transfer, patient falling to the floor. >10 Numbers, Contact Manufacturer The Vitrax II product is being recalled because during routine stability testing, it was discovered that a sample tested at the three month time point had a ph value of 7.70 which exceeded the ph specification range of 6.8 to 7.5 resulting in a lab investigation. The investigation revealed that some units from different lots post ETO sterilization have a ph greater than the upper ph limit of 7.5. The highest value was found to be 8.29. N/A The TECNIS 1-Piece Intraocular Lenses (IOLS) are being recalled because the haptics of some TECNIS 1-Piece IOLS (model ZCB00) have adhered to the lens optic after insertion into the eye. This situation can lead to additional manipulation to separate the haptics from the optic during surgery which could lead to an injury. A) 4230260ppc Review of test records indicated that the seven impacted Powerhart G3 AEDS B) 4226121 manufactured by Cardiac Science Corporation (CSC) may not have received adequate C) 4237595 testing prior to being shipped from the factory. D) 4183220 E) 4218441, 4153329, 4153683 A) 2012-06 AA The master carton and the individual dressing packages are labelled correctly, however the B) 2012-10 XT boxes that contain the individual dressing packages were labelled for Tegaderm Hydrocolloid thin dressing, catalogue # 90022. 2937776 for EZManager Max CD, French Compact discs received for EZManager Max Diabetes Management Software packages 2936068, 2938247, 2962490 for EZManager were identified as being blank when used in a computer. Max CD, English 2749789 Expired OneTouch SureStep Test Strips (lot#274789) were shipped to four Canadian wholesalers. A) Version 2.1.1 & All Previous Incorrect Zimmer implant data in Brainlab Software Knee leads to incorrect information for B) Version 2.1.1 & All Previous Zimmer Innex implants. C) Version 2.1.1 & All Previous 9ED058 Customer complaints regarding Dimension Vista Amon method. Siemens has confirmed a negative bias of up to 35% for level 1 quality control when calibrated with Chem 3 Calibrator lot 9ED058 vs. 9BD064. 1987, 3089 The potential hazard of fingers or hands getting caught exists when the patient holds on to the tomographic rod between the column/tube assembly and the spotfilm device. 9H2414, 9H2417, 9H2425, 9J2429, 9J2432, Decrease of medium selectivity for methicillin-sensitive Saphyloccus aureus strains before 9J2435, 9J2437 mediums expiration date.
57271, 57616, 57269, 57613
Rapid Eric Electronic Compendium Excor System-Connecting Set For Cannula Diagnostic Ultrasound Transducers / Probe i-CAT 3D Dental Imaging System Twist Drill 1.1x50mm 3.5mm stop Carto 3 EP Mapping System
Remel Inc. Berlin Heart GMBH Toshiba Medical Systems Corporation Imaging Sciences International, Inc. Walter Lorenz Surgical, Inc. Also trading as: Biomet Microfixation Biosense Webster (Israel) Ltd.
2009-12-21 2009-12-21 2009-12-21 2009-12-21 2009-12-21 2009-12-21
2009-10-30 51669 2009-10-02 51703 2009-10-30 51870 2009-10-30 51709 2009-11-18 51857 2009-11-25 51915
Type I Type I Type II Type II Type III Type II
RE8323600 A06-009, A09-012, A12-016 PVT-681MV 9140-0000-0000 01-7141 FG540000
1096277 526337 >10 Numbers, Contact Manufacturer ICU070488, ICU070518, ICU070519 537407, 536306, 535933 3257, 2246, 4203, 4166, 4184
i-CAT 3D Dental Imaging System Triage Tox Drug Screen PN 94400
Imaging Sciences International, Inc. Biosite Incorporated
2009-12-21 2009-12-21
2009-10-30 51944 2009-05-28 50030
Type II Type III
9140-0000-0000 94400
>10 Numbers, Contact Manufacturer >10 Numbers, Contact Manufacturer
Immucor Inc.
2009-12-21
2009-11-25 51956
Type II
87000
N/A
Hintegra Talar Cutting Guides Amplicor STD Specimen & Transport Kit
New Deal SA Roche Molecular Systems, Inc.
2009-12-21 2009-12-21
2009-10-20 51435 2009-11-27 51858
Type II Type II
Left Cutting Guide, Right Cutting Guide 20753920122
>10 Numbers, Contact Manufacturer K13333, K13334, K15491, K15492, 2036
BD 30ml Luer-Lok Syringes LabPro V3.01 Panel Update-01
Becton Dickinson Canada Inc. Siemens Healthcare Diagnostics Inc.
2009-12-21 2009-12-21
2009-11-26 51921 2009-11-30 51937
Type II Type III
309650 9800-3771
9175046 Software Version 3.01
Dade Hepzyme (B4240-10)
2009-12-21
2009-12-02 51994
Type III
B4240-10
528752
IW900 Series Infant Warmer
Fisher And Paykel Healthcare Ltd.
2009-12-21
2009-09-07 51309
Type III
IW910, IW920, IW930, IW932, IW934, IW950, IW980, WITH SUFFIX JEU
All Infant Warmers in Canada.
CyberKnife Robotic Radiosurgery System
Accuray, Inc.
2009-12-21
2009-06-22 50252
Type II
28000
C202
A) Intro-Flex Introducer Sets B) Percutaneous Sheath Introducer Kit A) VNS Therapy Demipulse Programmable Generator B) VNS Therapy Demipulse Duo Generator
Edwards Lifesciences LLC
2009-12-21
2009-05-21 48857
Type II
A) 1350BF85 B) I652BF85H, S5507BF85 A) N/A B) N/A
Cyberonics Inc.
2009-12-21
2009-12-03 52025
Type II
A) >10 Numbers, Contact Manufacturer B) 58511631, 58549300, 58606253, 58648812, 58496258, 58535112, 58604814, 58644423 A) All Lot Numbers B) All Lot Numbers
Error limited to the Rapid Yeast Plus Database regarding differentiation of C. albicans from C. dubliniensis potentially leading to false ID of isolate. It was observed that a too short cut of the adapter cannula combined together with certain conditions of stress may have a effect of leakage of the cannula. In ultrasound systems using the Ultrasound Convex Transducer PVT-681MV, the volume image acquired in 'plane C' is reversed horizontally. Fault in the brake system may result in gantry-overhead dropping quickly when the overhead is lowered. i-CAT classic containing electrical brake. Three manufacturing lots of Twist Drill 1.1 x 50mm, 3.5mm stop with J notch, part number 01-7141 were packaged and distributed without the instructions for use. Biosense Webster, Inc. has recently become aware of a potential hazard that may occur during the operation of the bloom DTU-215b cardiac stimulator (not a Johnson & Johnson device) in conjunction with RF generators and EP equipment, including the Carto 3 system. If RF energy and pacing stimuli are delivered simultaneously, across the same electrode pair, a DC voltage may be generated. This can cause micro-bubbles in the blood within the heart chamber. i-CAT classic units containing mechanical brake or containing dual brake system- fault in brake system may result in the gantry-overhead carriage moving below its limits. Biosite, Inc. initiates notice of correction for Triage Tox Drug Screen Kit, PN 94400. Boxes shipped after August 6, 2008 are misprinted on the right side of the box flap. The misprint incorrectly states "use EDTA whole blood or plasma sample only". The kit is intended for use with urine samples not blood or plasma. The instrument may generate a negative well interpretation for capture-R ready-screen or capture-R ready-ID assays and subsequent visual interpretation of those reactions are weak positive or questionable (equivocal). The width of the defective Talar Cutting Guides is too large, thus the medio-lateral cuts are too large compared to the Talar trial implant dimensions. Potential for the male swab to present a defectiveness where the cotton head of the swab may dislodge and/or unravel with minimal force. This could result in having cotton fibres remaining within the urethra during specimen collection of male patients. BD has determined that a small number of unit packages may have open seals which can adversely impact product package integrity/product sterility. Siemens Healthcare Diagnostics received customer complaints regarding QC isolates when tested on the walkaway instrument. Following the installation of LabPro 3.01 panel update 01 and utilization of the panel type POS combo 33 (PC33), an issue has been confirmed for QC isolates when tested on the walkaway instrument. This issue only applies to those that have installed the LP V3.01 panel update-01 (9800-3768 compact disk). QC issue affects combo type panels. Customer complaints regarding incorrect high APTT values that may be observed on heparin and heparin-free samples treated with lot 528752 of Dade Hepzyme when using lot 528752 of Dade Hepzyme with non-Siemens APTT reagents. Notifying users in Canada of updating cleaning instructions for the IW900 series infant radiant warmers. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held by Canadian customers which already cautions against using solutions containing specifically named chemicals. A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) and error 342 (deviation in absolute position value DSE - RDC) were displayed. Blue connector proximal to Tuohy-Borst hemostasis valve may fatigue, crack or separate, resulting in patency failure & potential blood loss where Intro-Flex Introducer secures a venous catheter. Enhanced labelling to prevent end of service (EOS) warning messages & reduced battery life resulting from electromagnetic induction (EMI), electrostatic discharge (ESD), or electro cautery exposure during surgery.

Medical Devices Recall Listings: 2009

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Medical Devices Recall Listings: 2009

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MEDICAL DEVICES RECALL LISTINGS: 2009

Hazard Classification Type II

Recall Posting Date

Recall Start Date

Reason for Recall

2009-01-05 2009-01-05 2009-01-05 2009-01-05 2009-01-05

Type II Type II Type II Type I Type II

Cell-Dyn Sapphire Analyzer

Abbott Laboratories Diagnostic Division

Philips Medical Systems Nederland B.V.

White Peaks Dental Systems Boston Scientific Neuromodulation Corporation

2008-11-26 44705 2008-09-26 45208

Dri-Lok Disposable Cannulas

Siemens Healthcare Diagnostics Inc.

2009-01-05 2009-01-05 2009-01-05

2008-11-11 44891 2008-12-08 45617 2008-12-11 45619

Type II Type II Type II

Maquet Critical Care AB Roche Diagnostics GMBH

2008-12-17 45668 2008-12-04 44645

Type II Type III

Labvision Corporation - Part Of Thermo Fisher Scientific

2009-01-05 2009-01-05 2009-01-05

2008-11-20 45563 2008-10-24 45706 2008-10-23 44571

Type II Type II Type II

Hamilton Star Archive Plate

2732709, 2742732, 2742744, 2714721, 2810259, 2811269 HL14301

Dominion Biologicals Ltd.

Intertan Entry Portal Handle

Smith & Nephew, Inc.

> 10 Numbers, Contact Mfr.

Medfusion Syringe Pump

Smith's Medical MD Inc.

>100 Numbers, Contact Mfr.

QP2508 Hand Pendant

M.C. Healthcare Products Inc.

Biophen Heparin 6 ref 221006 ECC.O Integrated Mini-Bypass System

Hyphen Biomed Sorin Group Italia S.R.L.

2008-11-25 45340 2008-12-31 45809

Type III Type II

221006 084221, 085339

80401, 81701, 83306 > 10 Numbers, Contact Mfr.

Trupath Biopsy Device

Boston Scientific Corporation

> 50 Numbers, Contact Mfr.

Boston Scientific Corporation Zimmer Inc.

2008-11-26 45615 2008-12-19 45916

M004218400 00-5971-050-12, 00-5971-050-14

Gold Probe Electrohemostatic Catheter Soft Tip Introducing Sheath

Boston Scientific Corporation Boston Scientific Microvasive

2008-12-31 45864 2008-12-31 45865

Varian Medical Systems, Inc.

Philips Medical Systems DMC GMBH

9890 010 03631

Modular Femoral Neck BiPAP Focus Ventilator Power Cord

Encore Medical, L.P. Respironics California, Inc.

2008-05-27 44847 2008-09-24 45154

53872833 Manufactured bef.Mar.27/ 08

Siemens Healthcare Diagnostics Inc.

Staphaurex Plus 150/450 BD Integra 1mlTB Syringe Ransel Kit

2009-02-02 2009-02-02 2009-02-02

2008-12-03 45985 2008-12-01 45355 2008-12-22 45734

Type II Type III Type III