BEUDAMED
    FDA Enforcement Class II Ongoing

    MultiDiagnost-Eleva

    Recall: Z-2404-2023 · Reported September 13, 2023

    Enforcement

    Recall Number
    Z-2404-2023
    Event ID
    92855
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Medical Systems Nederland B.V.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 13, 2023
    Initiation Date
    July 19, 2023
    Classification Date
    September 7, 2023
    Address
    High Tech Campus 36, N/A, Eindhoven, N/A, N/A, Netherlands

    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

    Code Info

    MultiDiagnost-Eleva

    Distribution

    US Nationwide Distribution

    Quantity

    5432 systems in total