Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.599 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Batec Mobility FSN_2021.001 - Batec Handbikes_update 1-12-2021
This letter is to inform you of a voluntary field action being initiated by Batec Mobility. The affected handbikes are the MINI, ...
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MicroPort Scientific Coöperatief, MSC_FSCA21110002, PROCOTYL P SUPERPATH IMPACTOR ADAPTOR
MicroPort has been made aware of 7 total incidents involving intra- operative complications due to jamming of the PROCOTYL® P ...
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CareDx AB FSN 2021-06 - SCORE 6
SCORE 6 sometimes incorrectly sets the Cq value to 0 (zero), which is interpreted as a negative call, for curves that have an ...
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Instrumentation Laboratory, FSCA-001-2021, HemosIL Liquid Anti-Xa
We hebben intern vastgesteld dat HemosIL Liquid Anti-Xa (artikelnr. 00020302601) niet voldoet aan de gelabelde aan boord ...
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Asid Bonz, 20211022-01, Sonosid Ultraschallgel
As a precautionary measure, we must ask you to stop using any products from the affected batch with immediate effect and to block ...
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B. Braun FSCA R-2021-004 - NEXADIA monitor (2) Set
Tijdens uitgebreide interne test werd duidelijk dat indien een klant afwijkt van de handleiding van NEXADIA-monitor en handmatig ...
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DIXI Medical S.A.S., FSN-FDS MED 3130, MICRODEEP Depth Electrode
This is to inform you that DIXI Medical S.A.S. has initiated a voluntary Field Safety Corrective Action (FSCA) of the MICRODEEP® ...
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Imtmedical ag, FSN-FSCA-2021-002, Diagnostic Package Pulse Oxymetry/Capnography
It has come to our attention that the CE mark with the Notified Body number (0124) of DEKRA Certification GmbH, was placed in ...
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Datascope Corp, 2249723-10/27/2021-003-C, Cardiosave Intra-Aortic Balloon Pumps
Datascope/Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue ...
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Henry Schein, 5866, IV Sets/ Accessories - Henry Schein
Deze veiligheidswaarschuwing maakt onderdeel uit van een groter Europees onderzoek naar vervalste certificaten. Doordat de ...