BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2524-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2524-2018
    Event ID
    80417
    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 1, 2018
    Initiation Date
    May 30, 2018
    Classification Date
    July 20, 2018
    Termination Date
    February 14, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    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 ).

    Code Info

    164033, 164071, 164034, 164095, 164057, 164054, 164055, 164080, 164072, 164088, 164048, 164094, 164068, 164019, 164013, 164073, 164025, 164026, 164027, 164060, 164083, 164021, 164066, 164075, 164074, 164084, 164086, 164098, 164028, 164053, 164063, 164064, 164024, 164049, 164018, 164022, 164061, 164100, 164097, 164011

    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