BEUDAMED
    FDA Recall Open, Classified

    MultiDiagnost-Eleva

    Recall: Z-2404-2023 · Initiated July 19, 2023

    Recall

    Recall Number
    Z-2404-2023
    Event Number
    92855
    Firm
    Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands
    FEI Number
    3000976525
    Product Code
    KPR
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 19, 2023
    Posted
    September 7, 2023

    Description

    MultiDiagnost-Eleva

    Reason

    A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

    Action

    Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide actions that should be taken by the customer/user in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. (Philips reference 2023-IGT-BST-011).

    Distribution

    US Nationwide Distribution

    Quantity

    5432 systems in total