BEUDAMED
    FDA Enforcement Class II Terminated

    SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

    Recall: Z-2755-2020 · Reported August 12, 2020

    Enforcement

    Recall Number
    Z-2755-2020
    Event ID
    85999
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2020
    Initiation Date
    January 8, 2020
    Classification Date
    August 5, 2020
    Termination Date
    June 21, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355, United States

    Description

    SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

    Reason

    Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis

    Code Info

    Serial Numbers: 5043 5085 5825 5234 5862 5751 5340 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962

    Distribution

    US Nationwide distribution.

    Quantity

    49 units