Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Philips Medical Systems DMC GmbH, 2021-PD-DXR-007/2022-PD-DXR-015, CombiDiagnost R90 ProxiDiagnost N90

    Philips has previously notified you of issues relating to potential component damage due to short circuit (CombiDiagnost R90, ...

    Waarschuwing | 16-03-2023

  2. Datascope Corp, 2249723-01/24/2023-003-C, Cardiosave Intra-Aortic Balloon Pumps

    There have been reported failures of the high pressure helium regulator which may cause a helium leak in the Cardiosave Hospital ...

    Waarschuwing | 16-03-2023

  3. CareDx AB, A-2023-007, Olerup QTYPE 11

    De mix op positie K21 in het O560-kanaal op de QTYPE-plaat lot E061 is ontworpen om het DPB1*17:01-allel te amplificeren, maar is ...

    Waarschuwing | 16-03-2023

  4. HYPHEN BioMed, FSN-FSCA29, BIOPHEN TM Protein C LRT

    The R2 of the products listed above contains Cesium Chlodride. Following information from our supplier, this substance has ...

    Waarschuwing | 16-03-2023

  5. Thermo Fisher Scientific, FSN-2023-001, Thermo Scientific Oxoid MacConkey Agar wout Salt

    Continued use of this lot may result in delay to patient treatment

    Waarschuwing | 16-03-2023

  6. Datascope Corp., 2249723-01/24/2023-002-C, Cardiosave Intra-Aortic Balloon Pumps

    As part of an ongoing investigation into unexpected shutdown of the Cardiosave IABP, the Datascope/Getinge Investigation team ...

    Waarschuwing | 16-03-2023

  7. VitreQ B.V., PRE-20220006, CryoTreQ

    Vitreq B.V. has become aware of two incidents which described that a CryoTreq device suddenly and forcefully disassembled after ...

    Waarschuwing | 15-03-2023

  8. Intuitive Surgical, Inc., ISIFA2022-14-C, da Vinci Xi and da Vinci X Surgical System

    Deze veiligheidsmededeling is bedoeld om u erop te wijzen dat een deel van de instrumentarmen (USM's) van het da Vinci X- en Xi ...

    Waarschuwing | 15-03-2023

  9. Inpeco SA, FSCA - AP2 - 202303 - 03, Aptio Automation

    The firmware of the modules listed above has the potential to mis-associate sample IDs leading to incorrect results or delayed ...

    Waarschuwing | 14-03-2023

  10. Inpeco SA, FSCA - ACP - 202303 - 02, Accelerator a3600

    The firmware of the modules listed above has the potential to mis-associate sample IDs leading to incorrect results or delayed ...

    Waarschuwing | 14-03-2023