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152 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. TROKAMED GmbH, 2023 VIG 105233 Morcellator, Griffmodul V2.0 5-times-use Morcellator System

    In rare cases, the Cutting Module may continue to rotate even though the activation switch on the Grip Module has been released.  

    Waarschuwing | 11-07-2023

  2. Olympus Medical Systems Corporation, FSN-QIL FY24-EMEA-10-FY24-OMSC-05, PowerSpiral Intestinal Videoscope PSF-1

    Recall - Market removal of PowerSpiral PSF-1 and associated accessories DPST-1 and PSCU Olympus had become aware of a situation ...

    Waarschuwing | 11-07-2023

  3. FSN-FSCA 272, Aesculap AG, Laparoscopic access

    We detected a non-conformity to the product specification of part number FF399R caused by a manufacturing deviation. The affected ...

    Waarschuwing | 10-07-2023

  4. Ambu A/S, FSN-Ambu2023FA00001, Ambu® aView 2 Advance

    Ambu heeft informatie ontvangen waarbij Ambu® aView™ 2 Advance op de grond is gevallen, waarna er kortsluiting optrad en het ...

    Waarschuwing | 06-07-2023

  5. Intuitive Surgical, Inc., ISIFA2023-02-R, Tip-Up Fenestrated Grasper

    Dit fabricageprobleem kan mogelijk resulteren in het (af)breken van het bovenste en/of onderste bekje.

    Waarschuwing | 16-06-2023

  6. Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0006, Hemospray Endoscopic Hemostat

    Adhesion of the powder to the endoscope or endoscope to the tissue can result in delay in treatment, mucosal tear, perforation, ...

    Waarschuwing | 31-05-2023

  7. Davol Inc. Subsidiary of C. R. Bard Inc, SUR-23-4657, Ventralight ST Mesh with Echo PS Positioning Sys

    BD heeft door klachten van klanten vastgesteld dat de e balloncomponent van het Ventralight ST-gaas met het Echo ...

    Waarschuwing | 22-05-2023

  8. DePuy Mitek, 2244073, Bioknotless Anchor

    This FSN is to alert users that applying bending force and/or bending force with impaction to the BIOKNOTLESS® Anchor Inserter ...

    Waarschuwing | 04-05-2023

  9. MAQUET Cardiovascular LLC, 2242352‐02.17.2023‐002‐R, Hemopro 2

    Maquet Cardiovascular, LLC/Getinge was notified by their sterilization provider (Steris) that for a period of roughly five ...

    Waarschuwing | 21-04-2023

  10. Olympus Medical Systems Corporation, QIL FY24-EMEA-01-FY23-OMTA-13 for MAJ-2315 Single, Single use Distal cover MAJ-2315

    Olympus has become aware that the Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the ...

    Waarschuwing | 20-04-2023

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