BEUDAMED
    FDA Enforcement Class II Ongoing

    Allura Xper series

    Recall: Z-2402-2023 · Reported September 13, 2023

    Enforcement

    Recall Number
    Z-2402-2023
    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

    Allura Xper series

    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

    Allura Xper series

    Distribution

    US Nationwide Distribution

    Quantity

    5432 systems in total