BEUDAMED
    FDA Recall Open, Classified

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    Recall: Z-1040-2023 · Initiated December 16, 2022

    Recall

    Recall Number
    Z-1040-2023
    Event Number
    91418
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 16, 2022
    Posted
    January 30, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    Reason

    In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

    Action

    On December 16, 2022, the firm initiated the recall to its affected customers via Urgent Medical Device Correction letters. Customers were instructed to do the following: Observe if the system suffers an abrupt shutdown. This can be caused e.g., by usage of the Emergency SHUTDOWN button, manually switching off via End session / Shutdown System command in the main menu, or by a long press on the power-on push button on the system console. In the event of an abrupt shutdown, restart immediately to verify system state and call service if necessary. The firm will provide a software patch to affected systems. Siemens's service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    609 US; 1627 worldwide