BfArM Recommendations
BfArM Recommendations include information about risks arising from medical devices and measures recommended by the Federal Institute in order to reduce or eliminate risks. The recommendations mainly derive from the evaluation of incident reports received under the medical devices vigilance system.
Further recommendations are only available in German language
| Date | Title | Link |
|---|---|---|
| 2012.02.02 |
BfArM’s updated assessment concerning oxygen concentrators Survey on the updated recommendation addressed to the local competent authorities concerning oxygen concentrators |
to article |
| 2011.12.30 |
FDA advice concerning Massager “ShoulderFlex” distributed by King International The US Food and Drug Administration (FDA) advises to stop using massager ShoulderFlex, distributed by King International (Beaverton, Oregon, USA). |
to article |
| 2011.11.16 |
Bankruptcy of NMT Medical Swissmedic advises to cease the use of septal repair devices that have been produced by the manufacturer NMT Medical, Inc. |
to article |
| 2011.09.28 |
BfArM’s assessment concerning oxygen concentrators Survey on the recommendation addressed to the local competent authorities concerning oxygen concentrators |
to article |
| 2011.03.31 |
Counterfeit product „Quick Vue Pregnancy Test“ Counterfeit product „Quick Vue Pregnancy Test“ abusing Core Technology Co. Ltd. |
to article |
| 2010.10.21 |
Silicone gel breast implants from Poly Implant Prothèse Company - Information |
to article |
| 2010.07.27 |
BfArM recommends not to implant silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP) |
to article |
| 2010.07.26 |
Counterfeit PROXIMATE PPH Procedure for Prolaps and Hemorrhoids Fa. Ethicon informs about the existence of a counterfeit product labeled PROXIMATE PPH Procedure for Prolaps and Hemorrhoids, product code PPH03, lot number F4N12N |
to article |
| 2010.04.19 |
Counterfeit dermal filler |
to article |
| 2009.03.30 |
Safety risk concerning dental unit PROPHY RELAX The patient chair of the dental unit PROPHY RELAX could suddenly drop down from the selected position. BfArM recommends all users to check on the bearings in the spindle drive. |
to article |
| 2008.11.07 |
Recommends to stop using of dialysers Due to insufficient cooperation of the manufactures Helbio SA (Switzerland), Idemsa ( Spain) and Fidia Srl (Italy), an appropriate risk assassment by BfArM is not possible. Thus, BfArM precautionarily recommends to stop using of dialysers produced by these manufacturers immediately. more information available in German |
to article |
| 2008.09.30 |
Information on Motorized Vehicle Victory Motorized Vehicle Victory manufactured by Pride Mobility Product Corp. has been recalled in the USA. Concerned are model number SC 1600 and SC 1700. |
to article |
| 2008.09.30 |
Inspection of the welding seams in care beds Residenz 98, manufactured by the former MTW Thale GmbH Welding seams in care bed Residenz 98, manufactured by the former MTW Thale GmbH, may crack at the framework mounting under continuous stress. |
to article |
| 2007.08.03 |
Remote controlled X-ray systems: risk of collision in case of vertical diagnostic procedures BfArM considers corrective measures concerning remote controlled X-ray systems mandatory in oder to reduce the risk of collision between moving parts and patients or users in case of vertical diagnostic procedures. |
to article |
| 2006.03.28 |
Information on Scooter Sungift 500 Scooter Sungift 500 manufactured by Sungift PLC (Great Britain) has been withdrawn from the Norwegian market in 2005 |
to article |