Field Corrective Actions - Archive 2006
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 488 (20 pages).
| Date posted | Reference-No. | Description | Product group |
|---|---|---|---|
| 2006.12.29 | 3491/06 |
Recall of Preservation tibial trays from DePuy DePuy are now recalling all lots of all catalogue numbers of Preservation tibial trays due to difficulties in seating the PE insert into the tray. Advisory Notice is only available in German language.
|
Non-active implants |
| 2006.12.28 | 3777/06 |
Information for the Varian High Energy Clinacs with Release 7 Software and the 4 MV/10 MV photon energy group from Varian Varian medical systems has issued an information concerning an anomaly (incorrect STT data for certain configurations) in Varian High Energy Clinacs with Release 7 Software and the 4 MV/10 MV photon energy group.
|
Radiotherapy/ Radiation protection |
| 2006.12.28 | 3756/06 |
Recall of the angioplasty catheter type 1 cm Peripheral Cutting Ballon from Boston Scientific The manufacturer Boston Scientific recalls several model and lot numbers of angioplasty catheters type 1 cm Peripheral Cutting Ballon. Due to specification deviation, the use of the affected products may potentially lead to vessel injury or an embolic event.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2006.12.28 | 3421/06 |
Recall of two lots of the Search Evolution Uni Knee Endoprosthesis from Aesculap Aesculap AG are recalling two lots of gliding surfaces of their Search Evolution Uni Knee Endoprosthesis due to a labelling error. Advisory Notice is only available in German language.
|
Non-active implants |
| 2006.12.28 | 3485/06 |
Recall of the VKS® Tibial Trials from Plus Orthopedics Recall of the VKS® Tibial Trials from Plus Orthopedics AG. These guides may have fixation pin hole diameters that are too small to accept the headed pins. There is a potential risk of surgery prolongation or due to the inaccuracy of a loosened trial.
|
Non-active implants |
| 2006.12.27 | 3658/06 |
Information concerning displacements of annotations by using the MPR-tool on a “portrait” monitor from Philips Philips Medical Systems has issued an information concerning displacements of annotations by using the MPR-tool on a “portrait” monitor for PACS EasyVision CL, DX, Home and RG Workstations with the Multi Planar Reformat (MPR) option. The involved product release levels are: R10.1L4, R10.1L6, R10.2L1 and R10.2L2.
|
Radiological technology |
| 2006.12.27 | 3599/06 |
Information about the cardiovascular X-ray Systems Allura Xper FD10/10 and Allura Xper FD20/10 from Philips Philips Medical Systems has issued an information about cardiovascular X-ray Systems Allura Xper FD10/10 and Allura Xper FD20/10. When pediatric axaminations are done it can come to a “Hang up” of the system.
|
Radiological technology |
| 2006.12.27 | 3641/06 |
Information concerning the HL 30 pumps from Maquet Maquet Critical Care has issued an information that in rare cases the offline mode of the HL 30 pumps will not be possible to activate as intended.
|
Surgical equipment/ Anaesthesia |
| 2006.12.27 | 3642/06 |
Information concerning the Heater Cooler Unit HCU 30 from Maquet Maquet Critical Care has issued an information concerning Overheating of the Heater Cooler Unit HCU 30 during the execution of the cleaning mode.
|
Surgical equipment/ Anaesthesia |
| 2006.12.27 | 3414/06 |
Corrective action for the IgG T on Integra 700/800 analyzers from Roche Corrective action of Roche for IgG T (all batches) on Integra 700/800 analyzers because of falsely-high values. Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2006.12.27 | 3620/06 |
Advisory Notice for the Guidant Acrobat Vacuum Stabilizer Systems from Guidant Advisory Notice of Guidant Corp. concerning the Guidant Acrobat Vacuum Stabilizer Systems. The firm has changed the shelf-life for the products from two years to one year. The risk of the old products is low.
|
Medical instruments |
| 2006.12.27 | 3794/06 |
Problems with the filter wheel of the Mammomat 1000/3000 Nova Systems from Siemens Siemens Medical Solutions has issued an information concerning a problem with the filter wheel of the Mammomat 1000/3000 Nova Systems. In rare cases a white shadow may appear due to incorrect positioning of the filter wheel.
|
Radiological technology |
| 2006.12.22 | 3059/06 |
Recall of the Femoral Venous Cannula Wire Reinforced from Sorin Group Recall of Femoral Venous Cannula Wire Reinforced (article number V172-28, lots see annex) from Sorin Group. The obturator could stick in the cannula`s lumen. The replacement of the cannula might cause a delay of the extra-corporeal circulation and an additional risk in emergency procedures.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2006.12.22 | 3348/06 |
Recall of different High Pressure Lines from Smith Medical The manufacturer Smith Medical Deutschland GmbH recalls all lot numbers of the High Pressure Line catalogue numbers 13-075, 13-100 and 13-125. The packaging might be defective and sterility could be compromised.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2006.12.22 | 2506/06 |
Advisory notice concerning the C3 blood line system from Gambro Dasco The manufacturer Gambro Dasco has isseud a follow-up advisory notice for the C3 blood line system. Users should avoid kink formation of the tubings.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2006.12.22 | 2947/06 |
Safety risk of the birthing beds models Birthright 35000 and 170000 from Huntleight Healthcare The company Huntleight Healthcare has issued an information to its customers about a safety risk of the birthing beds models Birthright 35000 and 170000. If the extreme foot end of the bed is loaded with more than 112 kg (with the backrest used) or 122 kg (with a flat backrest), the load starts to tip upwards the head end of the bed. All beds will be provide with warning labels.
|
General equipment for medical treatment |
| 2006.12.22 | 3677/06 |
Recall of the ISP-Modularer-Duokopf from ISP Recall of certain batches of ISP-Modularer-Duokopf by the company ISP GmbH due to a wrong labelling of the size of the product (see Advisory Notice). Advisory Notice is only available in German language.
|
Non-active implants |
| 2006.12.22 | 3662/06 |
Recall of the Tracheostoma Retainer Set manufactured by Willy Rüsch The distributor Teleflex Medical recalls several modell and lot numbers of the Tracheostoma Retainer Set manufactured by Willy Rüsch GmbH. The fixation of the tracheostomy tubus to the neckplate may be impaired.
|
Surgical equipment/ Anaesthesia |
| 2006.12.22 | 3742/06 |
Software upgrade of the ORTHOPHOS Plus with TSA from the manufacturer Sirona Dental Systems The manufacturer Sirona Dental Systems GmbH has issued an information on a software upgrade of its ORTHOPHOS Plus with TSA devices due to a possible contact of the X-ray tube and patients head.
|
Radiological technology |
| 2006.12.21 | 3374/06 |
Recall of the Powerlink with Visiflex infrarenal bifurcated delivery System from ENDOLOGIX ENDOLOGIX recalls the Powerlink with Visiflex infrarenal bifurcated delivery System due to an incident of separation of a part of the delivery catheter.
|
Non-active implants |
| 2006.12.21 | 3434/06 |
Recall of the central venous catheter Kids Cath NEO from Rüger Medical The manufacturer Rüger Medical GmbH recalls via his distributor Smith Medical Deutschland GmbH one lot number of the central venous catheter Kids Cath NEO. The mandarin may be too long at the tip, resulting in a risk of vessel perforation. Advisory Notice is only available in German language.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2006.12.21 | 3396/06 |
Recall of the Level 1 Normothermic I. V. Fluid Administration Set from Smiths Medical Smiths Medical ASD Inc. recalls several Lots of the Level 1 Normothermic I. V. Fluid Administration Set from the market. Due to a blockage of the recirculating warming fluid chanel non-tempered infusion fluid may be administered. The fluid warmer alarms and shutsdown automatically.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2006.12.21 | 3387/06 |
Stop of Delivery of the Metha Implant Components by Aesculap Stop of Delivery and advice for no further application of Metha Implant Components by Aesculap AG & Co. KG due to postoperative failures of modular Metha Adapters (see Advisory Notice).
|
Non-active implants |
| 2006.12.21 | 3669/06 |
Information concerning several products from Boston Scientific Boston Scientific asks his customers to review the devices Hemashield™ Gold™ Microvel™ Knitted Double Velour Graft , Hemashield™ Gold™ Woven Double Velour Graft, Hemashield™ Platinum™ Woven Double Velour Vascular Graft, Hemashield™ Finesse™ Ultra-Thin Knitted Cardiovascular Patch , Hemashield™ Platinum™ Finesse™ Ultra-Thin Knitted Cardiovascular Patch, Hemashield™ Knitted Double Velour Fabric, Hemashield™ Woven Double Velour Fabric in their inventory for signs of exposure to extreme heat and humidity.
|
Non-active implants |
| 2006.12.21 | 2624/06 |
Mandatory ugrade on all VISX™ WaveScan WaveFront™ Systems from Advanced Medical Optics The company Advanced Medical Optics (VISX USA) issued an information concerning the mandatory ugrade on all VISX™ WaveScan WaveFront™ Systems to a new software version. All future treatments must be calculated using version 3.67 or versions issued after 3.67.
|
Ophthalmological technology |
