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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

466 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Galil Medical Ltd, FSN-92611185-FA, Cryoablation Needles

    Boston Scientific (BSC) is initiating a Product Advisory for the IceFORCE™, IcePearl™, IceRod™, IceSphere™, IceSeed™, IceEDGE™ ...

    Waarschuwing | 19-11-2020

  2. Boston Scientific Corporation, FSN-92630745-FA, LOTUS Edge Valve System

    Boston Scientific (BSC) voert een vrijwillige verwijdering van ongebruikte voorraad van het LOTUS™ Edge klepsysteem uit.

    Waarschuwing | 16-11-2020

  3. GA Health Company Limited, FSN-QA-FSCA-2020-0001, Andorate® / PEXTAX Disposable Endoscope Valves Set (GAR004)

    GA Health Company Ltd. became aware that suction valve from Andorate® disposable endoscope valves set was sticky and/or broken ...

    Waarschuwing | 06-11-2020

  4. Stryker Joint Replacement, FSN-RA2020-2527314, Mako Integrated Cutting System (MICS)

    Stryker has initiated a voluntary, serial number specific recall for the Mako Integrated Cutting System (MICS).

    Waarschuwing | 03-11-2020

  5. Medtronic FA937 - Medtronic Cardioblate™ CryoFlex™ Surgical Ablation Devices

    Medtronic’s investigation process identified the above CryoFlex devices underwent a manufacturing process that may have resulted ...

    Waarschuwing | 30-10-2020

  6. Medtronic FA935 - Medtronic CoreValve Evolut R System_Evolut PRO System

    Deze kennisgeving is bedoeld om u belangrijke informatie te verstrekken over aanpassingen in de gebruikershandleidingen (IFU’s) ...

    Waarschuwing | 26-10-2020

  7. ViewRay Inc., FSN-3011233554-10-20-2020-001, Stereotacticradiotherapy/MRI System

    ViewRay Inc. has identified two situations where components of the receive coil can reach elevated temperatures which has the ...

    Waarschuwing | 23-10-2020

  8. Aesculap AG, FSN-FSCA249, AESCULAP AEOS

    With this letter Aesculap AG would like to inform you about a potential malfunction of product Aesculap Aeos®.

    Waarschuwing | 20-10-2020

  9. Mölnlycke Health Care AB, FSN-2020-09 (01), Mölnlycke® Procedure Trays & Single Packed Shielded Bladed Trocars

    Mölnlycke has become aware of situations where the protective flanges come away from trocar cannula.

    Waarschuwing | 19-10-2020

  10. Mölnlycke Health Care AB, FSN-2020-09 (02), TUR tray

    Mölnlycke has identified a potential safety issue. During a regular inspection, a fault in the sealing machine was identified.

    Waarschuwing | 19-10-2020

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