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  1. iMDsoft Ltd., MCR 151-2 MDSS ref. MDD23.144, MetaVision

    Bij gebruik van het bestelsjabloon met de hoeveelheid in gewichtseenheden wordt de bestel-/dosishoeveelheid berekend volgens het ...

    Waarschuwing | 12-07-2023

  2. Karl Storz SE Co. KG, 23-0008, FIVE S 5.3x65 sterile for single use

    Within the revalidation of the sterilization process the revalidation failed.

    Waarschuwing | 12-07-2023

  3. 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

  4. Maquet Cardiopulmonary GmbH, 812435, Rotaflow II drive flex.compact

    In October 2022 Maquet Cardiopulmonary received a complaint on issues connected to the yellow locking mechanism unlocking on ...

    Waarschuwing | 11-07-2023

  5. NVT GmbH, FSN-CAPA 23-10, ALLEGRA Transcatheter Heart Valve

    NVT has been informed that there has been a mix-up between an ALLEGRA THV 23 and an ALLEGRA THV 31.lf not identified prior to ...

    Waarschuwing | 11-07-2023

  6. Inter-med, Inc., FSN-RMA 41793, Septodont Parcan N NaOCL 3% Solution

    During an endodontic procedure involving the use of Parcan N 3% NaOCl for irrigation of the root canal, the patient experienced ...

    Waarschuwing | 11-07-2023

  7. 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

  8. FSN-AX008/23/S (FSCA), AX009/23/S (FSN), Siemens Healthcare GmbH, ARTIS pheno/icono

    Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur in ...

    Waarschuwing | 10-07-2023

  9. 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

  10. Olympus Winter and Ibe GmbH, FY24-EMEA-01, HF-resection electrode

    OLYMPUS has initiated this FSCA after receiving complaints where the loop wire at the distal end of the HF resection electrode ...

    Waarschuwing | 06-07-2023

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