20.08.2019
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Hypersensitivity reactions caused by dialysis filters
Severe hypersensitivity reactions caused by dialysis filters
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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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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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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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15.05.2018
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Discontinuation of the sale of the CE marked device ESSURE for permanent birth control
The manufacturer Bayer Vital GmbH stops distribution for CE marked devices Essure ESS 305 in Europe. The manufacturer points out that implanted devices may stay implanted safely.
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22.03.2019
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Device alert: Surgical mesh implant Rebound HRD / HRD-V manufactured by ARB Medical LLC (USA)
The surgical mesh implant Rebound HRD / HRD-V is a device for treatment of abdominal wall hernias. Fractures of its ring component may lead to in part severe complications, in these cases requiring explantation. Originally, the devices were not distributed in Germany. However, according to actual information to BfArM, an indirect distribution cannot be excluded.
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11.11.2020
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Damage of hip stem prostheses (neck area) caused by high-frequency cauterizing instruments (e. g. cautery knife)
BfArM has received several incident reports about fractures in the neck area of the stem hip implant made of titan alloy.
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28.08.2019
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Critical vulnerabilties in the real-time operating system VxWorks of the company Wind River
The BfArM points out critical vulnerabilties in the real-time operating system VxWorks of the company Wind River.
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19.08.2021
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Critical vulnerabilities in the real-time operating systems of various venders
The BfArM points out critical vulnerabilities in the real-time operating systems of various venders.
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09.10.2019
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Critical vulnerabilities in operating systems of different manufacturers
BfArM refers to a publication about potential cybersecurity vulnerabilities in operating systems of different manufacturers issued by FDA.
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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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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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19.04.2010
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Counterfeit dermal filler
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22.12.2016
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Cleaning and disinfection of heater-cooler-units (HCUs): possible influence on oxygenator integrity
Cleaning and Disinfection of heater-cooler-units (HCUs): possible influence on oxygenator integrity
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02.02.2012
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BfArM’s updated assessment concerning oxygen concentrators
Survey on the updated recommendation addressed to the local competent authorities concerning oxygen concentrators
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