16.12.2005
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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.
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28.03.2006
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Information on Scooter Sungift 500
Scooter Sungift 500 manufactured by Sungift PLC (Great Britain) has been withdrawn from the Norwegian market in 2005
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03.08.2007
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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.
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30.09.2008
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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.
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30.09.2008
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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.
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07.11.2008
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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
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30.03.2009
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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.
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19.04.2010
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Counterfeit dermal filler
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26.07.2010
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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
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27.07.2010
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BfArM recommends not to implant silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP)
BfArM recommends not to implant silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP)
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21.10.2010
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Silicone gel breast implants from Poly Implant Prothèse Company - Information
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31.03.2011
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Counterfeit product „Quick Vue Pregnancy Test“
Counterfeit product „Quick Vue Pregnancy Test“ abusing Core Technology Co. Ltd.
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28.09.2011
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BfArM’s assessment concerning oxygen concentrators
Survey on the recommendation addressed to the local competent authorities concerning oxygen concentrators
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16.11.2011
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Bankruptcy of NMT Medical
Swissmedic advises to cease the use of septal repair devices that have been produced by the manufacturer NMT Medical, Inc.
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30.12.2011
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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).
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