Field Corrective Actions - Archive 2004 - 2005
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 513 (21 pages).
| Date posted | Reference-No. | Description | Product group |
|---|---|---|---|
| 2005.12.30 | 2766/05 |
Risk of breakage in the backrest of the beds Arminia 2, Westfalia 3, Theutonia 3 and Fortuna from Burmeier Burmeier GmbH informs German customers about the risk of breakage in the backrest by overloading. It concerns the bed types Arminia 2, Westfalia 3, Theutonia 3 and Fortuna, produced between 2001 and March 2003.
|
General equipment for medical treatment |
| 2005.12.30 | 3151/05 |
Recall of the Vario Knee System Resection Guide Femoral Distal from Plus Orthopedics Recall of the VKS (Vario Knee System) Resection Guide Femoral Distal (article number 1214122, Index A, lots PI.79 and PI.80) by Plus Orthopedics AG. There is a risk, that the weld holding the superior adjustment knob fails, whereby the arm separates from the distal femur resection guide. Advisory Notice is only available in German language.
|
Medical instruments |
| 2005.12.30 | 2943/05 |
Change of the German instruction for use for the TEC-5500 from Nihon Kohden Nihon Kohden informs about a change of the German instruction for use. Instead of 60 charging/decharging-cycles the TEC-5500 can only perform 20 cycles without a break. Advisory Notice is only available in German language.
|
Medical electronics / Electromedical devices |
| 2005.12.30 | 3010/05 |
Risk with the Prisma 2K from Siemens The company Siemens Audiologische Technik GmbH informs business partners and parents about the risk of swallowing the battery when the hearing aid Prisma 2K is worn by small children. Due to possible malfunctions of the locking mechanism all units must be checked.
|
Medical electronics / Electromedical devices |
| 2005.12.30 | 1388/05 |
Recall of the Linvatec 300 Watt Xenon Light Source The company ConMed Linvatec Corporation informed about a recall of the Linvatec 300 Watt Xenon Light Source. A surface contamination on optical components may lead to an inadaquate illumination of the surgical site.
|
Optics / Precision mechanics |
| 2005.12.30 | 3220/05 |
Boston Scientific recalls the Flextome Cutting Balloon™ Device Monorail™ Delivery System and Peripheral Cutting-Balloon Microsurgical Dilatation Device
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2005.12.30 | 1899/05 |
Advisory notice from Gambro for the Nephral ST dialyzers The manufacturer Gambro informs via advisory notice about the anticoagulation strategy and de-aeration procedure while using the Nephral ST dialyzers.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2005.12.30 | 3130/05 |
Additional warning from Baxter BioScience for the product CoSeal Additional warning statement of Baxter BioScience concerning their product CoSeal in order to prevent any pacing wires, lines etc from being sealed to the surface of internal organs.
|
Non-active implants |
| 2005.12.30 | 3250/05 |
Corrective action and recall of Beckman Coulter for Cytomics FC 500 with CXP Software Corrective action and recall of Beckman Coulter for Cytomics FC 500 with CXP Software (Version 2.0) because of a risk of sample misidentification under certain circumstances. Customers were informed about the problem and how to avoid it. A software upgrade will be developed.
|
In-vitro diagnostics |
| 2005.12.30 | 3191/05 |
Recall of Diamed for ID-Anti-Lea and AP P1-Lea-Leb-Lua-Lub-CtI Recall of Diamed for ID-Anti-Lea (lot number 50241.30.02) and AP P1-Lea-Leb-Lua-Lub-CtI (lot number 50371.02.01) because of a decreased reactivity and risk for false negative results. Customers were informed to discard the affected batches. Advisory Notice is only available in German language.
|
In-vitro diagnostics |
| 2005.12.30 | 3066/05 |
Corrective action and recall of Immucor for the Galileo Analyzer
|
In-vitro diagnostics |
| 2005.12.30 | 2987/05 |
Safety risk in the wheel suspension of the three-wheeled chair Cheetah from R82
|
Orthopedy/ Rehabilitation |
| 2005.12.30 | 0610/05 |
Casters may break at Mobile Videocarts from Karl Storz The manufacturer Karl Storz GmbH notified customers of the Mobile Videocart 29003 NEAG, WGAG, NAG and NEG of the possibility that casters may break. The thread of the casters are not glued safely for a limited number of products. This may cause a broken threaded bolt. The carts will be serviced to ensure the safety.
|
Surgical equipment/ Anaesthesia |
| 2005.12.30 | 3343/05 |
Problems with the Neonatal Ventilator Baylog 8000plus from Dräger Dräger Medical informs that with very low PEEP settings, a disconnection of the patient system is not reliably detected or alarmed by the Neonatal Ventilator Baylog 8000plus with software version 5.n.
|
|
| 2005.12.30 | 1470/05 |
Corrective action of the ERBE Helix Hydro-Jet The company ERBE Elektromedizin GmbH notified customers of the water jet dissector ERBE Helix Hydro-Jet of a corrective action. Due to mechanical damage of the pressure sensor an uncontrolled exceeding of the fluid pressure is possible. Devices with the article number 10139-000 and serial numbers below 0136 can be affected.
|
Surgical equipment/ Anaesthesia |
| 2005.12.29 | 2884/05 |
Recall of the product Removable T-Handle Recall of the product Removable T-Handle (serie revision G, catalogue number 803-00-047). The European Authorised Representative informed about a lot recall, because an assembly error was detected. The error could lead to a delayed surgery or a revision surgery, if small pieces are becoming lost.
|
Medical instruments |
| 2005.12.29 | 3139/05 |
Becton Dickinson recalls several lot numbers of the peridural anaesthesia products The manufacturer Becton Dickinson recalls several lot numbers of products for the peridural anaesthesia (BD Durasafe Plus CSE-Kits, BD Adjustable Durasafe Plus CSE-Kits, BD Perisafe Plus Peridural Kits) from the market. These lots may include a fault resulting in catheters coming loose from the conector.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2005.12.29 | 3042/05 |
Baxter recalls the Intercept BC Platelet Pooling Set and Buffy Coat Pooling Set The manufacturer Baxter recalls several lots of the product Intercept BC Platelet Pooling Set and Buffy Coat Pooling Set, article numbers KGR5630B, RGR5630B, SGR7012 and SGR7039. In Germany only three lot-numbers of RGR5630B are affected. A tubing may be defect, and sterility of the fluid pathway may be compromised. Advisory Notice is only available in German language.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2005.12.29 | 2707/05 |
Terumo Cardiovascular Systems recalls the Sarns Soft Flow Aortic Cannulae with Suture Flange Terumo Cardiovascular Systems Corp., USA, informed about the recall of Sarns Soft Flow Aortic Cannulae with Suture Flange (catalog number 7080, batches see annex). The sterility of the punctured packages may be affected.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2005.12.29 | 3189/05 |
Boston Scientific recalls Stainless Steel Greenfield™ Vena Cava Filter Boston Scientific recalls Stainless Steel Greenfield™ Vena Cava Filter with 12 French Introducer Femoral System. Detachments of the bond between the carrier capsule and the outer sheath were reported.
|
Non-active implants |
| 2005.12.29 | 3099/05 |
Corrective action and recall of Dade Behring for the BEP 2000 and the BEP 2000 Advance System
|
In-vitro diagnostics |
| 2005.12.29 | 3051/05 |
Customer Information concerning the surgical lights Admeco-Lux The Admeco AG send a Customer Information concerning the surgical lights Admeco-Lux. The infrared caps of the lights are wear parts, whose transparency reduces by the daily disinfecting and repeated heating, which can lead to overheating, substantial discolorations and cracks in the material. There is the risk that plastic parts separate during an operation. The users are requested according to the operating instructions to check the IR caps regularly and exchange it in time.
|
Surgical equipment/ Anaesthesia |
| 2005.12.22 | 2984/05 |
Potential therapy failure of Sigma pacemakers from Medtronic
|
Active implants |
| 2005.12.22 | 2979/05 |
OrbusNeich recalls the SafeCut Coronary Dilatation Catheter OrbusNeich Medical Co. Ltd. recalls special lots of the SafeCut Coronary Dilatation Catheter from the market. When the balloon pressure somewhat exceeds the rated burst pressure it may burst. Additionally the manufacturer advises the customers per advisory notice to use the catheter as intended.
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Injection/ Infusion/ Transfusion/Dialysis |
| 2005.12.22 | 3110/05 |
Corrective action and recall of Ortho Clinical Diagnostics for AutoVue Innova/Ultra Corrective action and recall of Ortho Clinical Diagnostics for AutoVue Innova/Ultra (Software version 1.02) because under certain circumstances the link between the samples and the results generated can be lost and as a result of this disruption some of the results generated will not be used in the final interpretation of the test results. Customers were informed about the problem and how to avoid it. A new software version will be developed.
|
In-vitro diagnostics |
