BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

    Recall: Z-2587-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2587-2023
    Event ID
    92901
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2023
    Initiation Date
    August 15, 2023
    Classification Date
    September 14, 2023
    Address
    Veenpluis 4-6, Best, N/A, Netherlands

    Description

    Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

    Reason

    A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

    Code Info

    Models: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 No UDI-DI information for foot switch component.

    Distribution

    Worldwide distribution

    Quantity

    19,115 systems