BEUDAMED
    FDA Recall Terminated

    ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

    Recall: Z-2524-2018 · Initiated May 30, 2018

    Recall

    Recall Number
    Z-2524-2018
    Event Number
    80417
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 30, 2018
    Terminated
    February 14, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

    Reason

    During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

    Action

    An Urgent Medical Device Correction notification was distributed to customers on 5/30/18. The notification provided the following information to customers: Siemens will correct the error by inspecting all affected ARTIS Pheno systems. As an immediate measure to prevent movement stops during a C-arm rotation followed by a C-arm drop, the maximum rotation speeds will be reduced. This correction limits the maximum manual LAO/RAO rotation from 25/sec to 20/sec and Cran/Caud rotation from 20/sec to 10/sec. All other system parameters as well as 3D acquisition and Perivision/Peristepping remain unaffected. You may continue to use the ARTIS Pheno system while awaiting implementation of the corrective action. Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX004/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. Additionally, Siemens is developing a solution to restore the system back to the original settings. This solution will be distributed to all affected customers upon completion.

    Distribution

    The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.

    Quantity

    40 in the United States