BEUDAMED
    FDA Enforcement Class II Ongoing

    ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

    Recall: Z-0523-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0523-2024
    Event ID
    93338
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2023
    Initiation Date
    October 17, 2023
    Classification Date
    December 9, 2023
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

    Reason

    Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.

    Code Info

    UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100

    Distribution

    US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa

    Quantity

    38 worldwide, 11 US