News
In the following you can find information about current topics related to medical devices.
Please note that there is further information about Field Corrective Actions on the following website:
| Date | Title | Link |
|---|---|---|
| 2012.09.28 |
FlowMedical PTA-CATH 5,0 x 100 Angioplasty Catheter of the manufacturer itm FlowMedical GmbH The recommendation that the Angioplasty Catheter FlowMedical PTA-CATH 5,0 x 100 of the manufacturer itm FlowMedical GmbH should not be used anymore is cancelled by BfArM |
to article |
| 2012.08.22 |
Recommendations on the approach to patients with Riata and Riata ST leads (St. Jude Medical) The German Cardiac Society (DGK) has published recommendations regarding patients with silicone insulated defibrillation leads Riata and Riata ST of St. Jude Medical. |
to article |
| 2012.07.30 |
Non CE-marked portable dental X-ray units MHRA has issued Medical Device Alert MDA/2012/046 regarding non CE-marked portable dental X-ray units and recommends to stop using this. |
to article |
| 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 |
| 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 |
| 2010.03.10 |
EU Medical Device Vigilance Exchange via xsd XSD's for manufacturers, who wish to report directly from their database into an XML file that fulfils the requirements for electronic reporting. |
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 |
| 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 |
| 2005.12.16 |
FDA advice concerning Enclosed Bed Systems manufactured by Vail Products The US Food and Drug Administration (FDA), advises to stop using enclosed bed systems, manufactured by Vail Products (Toledo/Ohio, USA). Concerned models are Vail 500, Vail 1000 and Vail 2000. |
to article |