Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Olympus Medical Systems Corporation, Single Use Distal Cover
Olympus has become aware that the Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use.
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FUJIFILM medwork GmbH, Polypektomy snare
In some cases, at specific lots of artlcle POL-X1-10-23-220-OL (Polypektomy snares) the components were connected incorrectly ...
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Samsung Electronics Co, FSCA-GM85.231117-1, GM85
Tijdens een bemonsteringsinspectie van GM85 -systemen werd Samsung Electronics zich ervan bewust dat tijdens de productiefase van ...
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Ambu A.S, Ambu2023FA00002, Ambu aView 2 Advance
Ambu has received information on two incidents where Ambu® aView™ 2 Advance caught fire when mounted on the VESA holder of the ...
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Roche Molecular Systems, Inc., select Roche assays used on the cobas 5800.6800.8800 systems
The CAPA investigation determined that the root cause of the issue is the influenza A target design of the assay, which was not ...
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Medtronic, FA1324, Neuroscience CST StealthStation S7 Cranial Software v3.1.4
Medtronic identified two software anomalies in StealthStation™ Cranial Version 3.1.4 software that can occur under specific ...
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Medex, FSCA 23024, Secufill
Some particulates have the potential to detach from the device and, in rare circumstances, might enter the fluid path and be ...
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Stryker Joint Replacement, RA2023-3471895, Scorpio, Duracon, PCA, Trident
The industry guidance for storage duration of Ultra High Molecular Weight Polyethylene (UHMWPE) raw material used in the ...
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Medtronic Navigation Inc., FA1384, Pin, 9733235/9733236, 100MM/150MM, Sterile, Perc Ref
Medtronic is zich ervan bewust geworden dat bepaalde partijen percutane pennen (zie Tabel 1) een kruispen bevatten waardoor de ...
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New Gene (Hangzhou) Bioengineering Co., Ltd., COVID-19 Antigen Detection Kit - Nasal Swab
Er is gerapporteerd dat er onvoldoende vloeibare buffer bij het product aanwezig is.