Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

468 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Maquet Cardiovascular, 2242352-06/07/2024-001-R, Vasoview Hemopro Endoscopic Vessel Harvesting Sys.

    Maquet Cardiovascular, LLC (MCV), a subsidiary of Getinge, is initiating a voluntary Medical Device Removal for the VasoView ...

    Waarschuwing | 11-07-2024

  2. Medtronic Xomed, Inc., FA1422, NIM Vital™ Console, NIM Vital™ Patient Interface 4 Channel, NIM Vital™ Console Refurbished, NIM Vital™ Patient Interface 4 Channel Refurbished

    Deze corrigerende veiligheidsactie is ingezet omdat klanten meldden dat er bij hen foutnegatieve responsen waren opgetreden ...

    Waarschuwing | 04-07-2024

  3. Boston Scientific Corporation, 97223381, Capio™ SLIM Suture Capturing Device

    Boston Scientific start met de verwijdering van bepaalde partijen Capio SLIM-hechtdraadplaatsingsapparaten (Capio SLIM) vanwege ...

    Waarschuwing | 03-07-2024

  4. 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 ...

    Waarschuwing | 01-07-2024

  5. 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 ...

    Waarschuwing | 01-07-2024

  6. 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 ...

    Waarschuwing | 24-06-2024

  7. 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 ...

    Waarschuwing | 20-06-2024

  8. 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 ...

    Waarschuwing | 18-06-2024

  9. 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 ...

    Waarschuwing | 03-06-2024

  10. 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 ...

    Waarschuwing | 03-06-2024