BEUDAMED
    FDA Recall 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 · Initiated January 8, 2020

    Recall

    Recall Number
    Z-2755-2020
    Event Number
    85999
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 8, 2020
    Terminated
    June 21, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    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

    Action

    Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via XP028/19/S January 2020. Additionally, a solution to eliminate the root cause of this problem is being distributed via XP008/20/S March 2020. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. New corrective software VE10Y became available June 22, 2020, and it is being distributed via an Update Instruction XP008/20/S. This update fixes the initial reported issue and the sporadic image loss issue noted by customers who had already installed VE10W (XP029/19/S). The original Customer Safety Advisory Notice (XP028/19/S) and the information letter distributed in March 2020 remain applicable. This resolution will be provided free of charge. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action . Questions contact the service organization for an earlier appointment at 1-800-888-7436

    Distribution

    US Nationwide distribution.

    Quantity

    49 units