Field Corrective Actions - Archive 2009
Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use. In general, the manufacturer implements field corrective actions by sending an advisory notice to inform operators and users about risks of medical devices, and to advise on what action should be taken to protect the health or the safety of patients, users or other persons. For example, advisory notices may contain the information from the manufacturer that he voluntarily recalls a medical device.
Please note that advisory notices are issued by the manufacturer, the authorized representative or the importer of medical devices. The respective company takes the responsibility for all information given in the advisory notice.
Search results 1 to 25 from a total of 761 (31 pages).
| Date posted | Reference-No. | Description | Product group |
|---|---|---|---|
| 2009.12.30 | 4724/09 |
Recall for Oxoid Brain Heart Infusion, Oxoid Recall of Oxoid for Oxoid Brain Heart Infusion (Lot-No. 762133, 762134, 793640, 819692 and 819693) because of impaired growth of Streptococcus pneumoniae. Customers were advised to discard the affected batches.
|
In-vitro diagnostics |
| 2009.12.30 | 4687/09 |
Corrective action for TriniCHECK Control Level 1 and TriniCHEK Control Level 2, Trinity Biotech Corrective action of Trinity Biotech for TriniCHECK Control Level 1 (Lot-No. T145019) and TriniCHEK Control Level 2 (Lot-No. T093001 and T086004) due to incorrect reference values and assigned ranges. Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2009.12.29 | 4727/09 |
Safety Notice for ARTISTE™ MV linear accelerators with syngo® RT Therapist, Siemens Siemens Medical Solutions has issued a Field Safety Notice concerning the ARTISTE™ MV linear accelerators with syngo® RT Therapist versions 4.1.122_Patch03, 4.1.125_Patch03 and 4.1.125_Patch14. The Adaptive Targeting calculates incorrect table shift coordinates if two or more treatment plans with different isocenter positions are stored in one course in LANTIS™.
|
Radiotherapy/ Radiation protection |
| 2009.12.29 | 0646/09a |
Corrective action of the AED 10 and MRL Jumpstart defibrillators, WelchAllyn WelchAllyn Protocol, Inc. has issued a follow up reminder Field Safety Notice to a previous corrective action of the AED 10 and MRL Jumpstart defibrillators initiated in February 2009. Devices with software versions 2.03.XX, 2.04.XX or 2.05.XX could unexpectedly shutdown if both of the following conditions are met: 1. The pads are attached to the patient prior to turning on the device and 2. The device is set to deliver an initial shock of 150 Joules energy.
|
Medical electronics / Electromedical devices |
| 2009.12.29 | 4709/09 |
Corrective action for optional NIBP units, installed in defibrillators cardioLife, Nihon Kohden Nihon Kohden Europe GmbH has issued a Field Safety Notice concerning a corrective action of optional NIBP units models CY-0010 and SG-761VK, installed in defibrillators cardioLife TEC-7621K, TEC-7631K, TEC-7721K and TEC-7731K for monitoring of noninvasive blood pressure. Due to a malfunction by setting the alarm limits in the neonatal operation mode the alarm is impaired or is prevented completely.
|
Medical electronics / Electromedical devices |
| 2009.12.29 | 4773/09 |
Corrective action for the UniCel DxH 800 Coulter Cellular Analysis System, Beckman Coulter Corrective action of Beckman Coulter for the UniCel DxH 800 Coulter Cellular Analysis System due to issues related to host transmissions. Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2009.12.29 | 4547/09 |
Corrective action for Galileo Echo, Immucor Corrective action of Immucor for Galileo Echo analyser due to erroneous well interpretationen for Capture-R Ready-Screen assays and Capture-R Ready-ID assays. Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2009.12.28 | 4631/09 |
Recall for searcher-cores, Richard Wolf GmbH Richard Wolf GmbH recalls searcher-cores model 892501625 of batch 1076315. Only the German market ist affected. Advisory Notice is only available in German language.
|
Optics / Precision mechanics |
| 2009.12.28 | 4718/09 |
Safety Notice for ARTISTE™ digital linear accelerator, Siemens Siemes Medical Solutions has issued a Field Safety Notice concerning the ARTISTE™ digital linear accelerators with syngo® RT Therapist version 4.1 connected to LANTIS™. In case of a failed data transfer fractions delivered on the ARTISTE might not be recorded in LANTIS and subsequently patients might be mistreated.
|
Radiotherapy/ Radiation protection |
| 2009.12.28 | 4683/09 |
Safety Notice for Confirma, Inc.´s CADstream®, GE Healthcare GE Healthcare has issued a Field Safety Notice concerning a problem of using Confirma, Inc.´s CADstream® in conjunction with GE Healthcare´s PURE option for dynamic MRI Imaging.
|
Electromedical fields |
| 2009.12.22 | 4378/09 |
Corrective Action for Galileo Echo, Immucor Corrective Action of Immucor for Galileo Echo because of possible problem while performing QC testing. The customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2009.12.22 | 4623/09 |
Information for the monitor units Eclipse™, Varian Varian Medical Systems has issued a field safety notice concerning a problem in Eclipse™ for erroneous MU for multiple carriage group dynamic MLC fields. Affected Produkts are Eclipse-Client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5 (builds 8.2.x).
|
Radiotherapy/ Radiation protection |
| 2009.12.21 | 4714/09 |
Information for the Digital Image Capture System SDC HD 0240050888 and 0240050888i, Stryker Stryker Endoscopy has issued a Field Safety Notice concerning a corrective action of the Digital Image Capture System SDC HD 0240050888 and 0240050888i. After 31th December 2009 saved files will not be assigned with the correct time/date and the system date will re-start from 1st October 2001. The affected devices should not be used until a software upgrade will be carried out.
|
Radiological technology |
| 2009.12.21 | 4484/09 |
Information for TriniCHECK Control Level 3, Trinity Biotech Trinity Biotech GmbH has issued an information about a Typographical error in the TriniCHECK Control Level 3 lot specific insert. The Factor VII assigned range is incorrect.
|
In-vitro diagnostics |
| 2009.12.21 | 4339/09 |
Recall of Male Swab, Roche Recall of Roche Molecular Systems Inc. for Male Swab packaged within the AMPLICOR STD Swab Specimen and Transport Kit . CE IVD, Lots K13333, K13334, K15491 and K15492, because the cotton head of the Male Swab may dislodge and/or unravel. The customers were informed about the problem and requested to discontinue use of the lots affected.
|
In-vitro diagnostics |
| 2009.12.21 | 4499/09 |
Information for the automated external defibrillators HeartStart HS1 and HeartStart FRx, Philips Philips Healthcare has issued a Field Safety Notice concerning a corrective action of the HeartStart HS1 (models M5066A/67A/68A) and HeartStart FRx (model 861304) automated external defibrillators (AED) manufactured in October 2009. The affected devices may contain a defective capacitor. A capacitor failure could prevent the AED from delivering effective defibrillation therapy when indicated. The affected devices will be replaced.
|
Medical electronics / Electromedical devices |
| 2009.12.21 | 4152/09 |
Information for Elecsys Thyroglobulin, Roche Diagnostics Roche Diagnostics GmbH has issued an information about the fact that Elecsys Tg (Thyroglobulin) lot no. 155166 shows a positive bias in combination with CalSet lots 151605, 152737 and 155488.
|
In-vitro diagnostics |
| 2009.12.21 | 4578/09 |
Safety information for Twist Drill, Biomet Microfixation The manufacturer Biomet Microfixation Inc. informs with a safety information about the missing of the Instructions for Use for the device Twist Drill (Model 01-7141, lot numbers 537407, 536306, 535933). Used more than once the drill may become dull.
|
Medical instruments |
| 2009.12.21 | 4641/09 |
Field Safety Notice for Navigation Headset Operator's Manual, GE Healthcare GE Healthcare has issued a Field Safety Notice concerning the Navigation Headset Operator's Manual update for the following surgical navigation systems: OEC IT3000, IT2500, IT2500 Plus, IT3500, IT3500 Plus, ConneCTstat and ConneCTstat Plus. The ENT registration Headset must not be used in the inverted position for any CT scans or surgical procedures.
|
Radiological technology |
| 2009.12.21 | 3905/09 und 3906/09 |
Information for CelonLab POWER, Celon The company Celon AG notified customers of the RF generator CelonLab POWER to wait for a successful completion of the automatic self test before starting the application on the patient. In two cases devices could not be switched on due to a technical failure when patients were already prepared for the surgical intervention.
|
Medical electronics / Electromedical devices |
| 2009.12.21 | 4617/09 |
Recall of Dimension Vista LOCI Reaction Vessel, Siemens Recall of Siemens Healthcare Diagnostics for Dimension Vista LOCI Reaction Vessel (KS855), lot NH29-188-09, because of defect in the molding. The customers were informed about the problem and requested to discard the lot.
|
In-vitro diagnostics |
| 2009.12.21 | 4477/09 |
Field Safety Notice for electrophysiology system Carto 3, Biosense Webster Biosense Webster has issued a Field Safety Notice concerning the electrophysiology (EP) system Carto 3. During operation of a Bloom EP Stimulator device in conjunction with radiofrequency (RF) generators and other EP equipment, including the Carto 3 a potential hazard exists of formation of micro-bubbles in the blood within the heart chamber. Recommendations when connecting an EP Stimulator to Carto 3 system shall avoid possible patient injury.
|
Medical electronics / Electromedical devices |
| 2009.12.16 | 4652/09 |
Recall for Brain Heart Infusion Broth, OXOID Recall of OXOID Deutschland / Thermo Fisher Scientific for Brain Heart Infusion Broth TV5010D because of variable growth outcomes with Streptococcus pneumoniae ATCC 6305. The customers were requested to destroy the lots affected.
|
In-vitro diagnostics |
| 2009.12.15 | 4592/09 |
Corrective action for Coagulation analyzer CA-1500, Sysmex Corrective action of Sysmex for analyzers of the CA-1500 series because of erroneous results for PTT and aPTT due to a malfunction inside the aspiration sample arm tubing. Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2009.12.15 | 4422/09 |
Recall for Dade Hepzyme, Siemens Recall of Siemens for Dade Hepzyme (Lot-No. 528752) due falsely-positive results of APTT. Customers were advised to discard the affected batch.
|
In-vitro diagnostics |
