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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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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28.09.2012
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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
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20.08.2019
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Hypersensitivity reactions caused by dialysis filters
Severe hypersensitivity reactions caused by dialysis filters
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07.01.2019
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Increased occurrence of corneal haze after implantation of the Raindrop Near Vision Inlay (FDA Safety Communication)
According to new clinical study results, the Raindrop implant (Brand name: Raindrop Near Vision Inlay; manufacturer: ReVision Optics) may lead to an increased occurrence of corneal haze.
The BfArM would like to refer to a recent FDA Safety Communication and publication by the medical society GSCRS in this context and strongly recommends against further implantation of the implant (§ 11 Abs. 2 MPSV).
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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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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Scooter Sungift 500 manufactured by Sungift PLC (Great Britain) has been withdrawn from the Norwegian market in 2005
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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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12.03.2013
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IV extension sets with multiple ports and vented caps
BfArM informs about the potential risk of air embolism when using IV extension sets with multiple ports and vented caps
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30.07.2012
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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.
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18.11.2014
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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.
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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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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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30.03.2009
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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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21.10.2010
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Silicone gel breast implants from Poly Implant Prothèse Company - Information
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