Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
465 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Olympus Europa SE & Co. KG, FY25-EMEA-09-FY23-OSTA-13-SoltiveWirelessFootswitch, Soltive Laser System
Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY25-EMEA-10-FY25-001 Broken Forceps Trays, Olympus Everest Bipolar Cutting Forceps
Olympus has received 15 complaints during the December 2018 – December 2023 timeframe from customers indicating fractures and ...
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Megadyne Medical Products, Inc., 2370372, MEGADYNE™ MEGA SOFT™ and MEGA 2000™ Reusable Patient Return Electrodes
Megadyne Medical Products, Inc. (“Megadyne”) has received reports of patient burns identified after surgical procedures in which ...
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Maquet Cardiovascular, LLC/Getinge, 2242352-05/21/2024-001-C, VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2
lf there is fluid ingress into the handle of the operating tool, the device may not provide cautery or may continue to provide ...
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3M Deutschland GmbH, FSCA 2024-05 Tegaderm, Tegaderm™ Film – Transparent Film Dressing
Deze corrigerende actie is gestart vanwege de identificatie van een productieprobleem. Voor het beoogde gebruik moet het product ...
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Atrium Medical Corporation, 3011175548-05/08/2024-001-R, Advanta VXT and Flixene Vascular Graft
Between 27 December 2023 and 17 April 2024, Atrium Medical Corporation/Getinge received eight (8) complaints reporting that the ...
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Integra LifeSciences (Ireland) Limited, 2024-HHE-006, Cusa Excel 23kHz Straight Handpiece
The decision to conduct a voluntary correction of the product was based on the following: through an internal investigation of ...
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Blue Belt Technologies, Inc, C-2024-03, Real Intelligence Cori
Klanten ervaren mogelijk wisselend zicht op de REAL INTELLIGENCE-trackerarrays.
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Medtronic Navigation Inc., FA1414, StealthStation® S8 Application - Software App 9735762 Stealth S8 Application
De StealthStation S8-app wordt gebruikt ter begeleiding van chirurgen bij chirurgisch genavigeerde procedures. Een ...
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Cook Incorporated, 2024FA0004, Ultrathane® Mac-Loc Locking Loop Multipurpose Drainage Catheter
Cook Medical heeft vastgesteld dat op de etiketten van hulpmiddelen uit de betrokken partij met hulpmiddelen een onjuiste ...