BEUDAMED
    FDA Enforcement Class II Ongoing

    AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

    Recall: Z-1000-2023 · Reported January 25, 2023

    Enforcement

    Recall Number
    Z-1000-2023
    Event ID
    91383
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2023
    Initiation Date
    December 9, 2022
    Classification Date
    January 19, 2023
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

    Reason

    There is potential for the footrest to detach from the patient table during use.

    Code Info

    All serial numbers 1) AXIOM Luminos TF, Material #10093902 (no UDI) 2) AXIOM Iconos R100, Material #05895151 (no UDI) 3) AXIOM Iconos R200 C69, Material #10093961 (no UDI) 4) AXIOM Iconos R200 C20, Material #10093962 (no UDI) 5) AXIOM Luminos dRF, Material #10094200 (no UDI)

    Distribution

    Worldwide distribution

    Quantity

    654 units