BEUDAMED
    FDA Enforcement Class II Terminated

    Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    Recall: Z-0854-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0854-2015
    Event ID
    69478
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    September 17, 2014
    Classification Date
    January 14, 2015
    Termination Date
    August 6, 2015
    Address
    40 Liberty Blvd, Mail Code: 65-1A, Malvern, PA, 19355-1418, United States

    Description

    Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    Reason

    The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.

    Code Info

    model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, with serial numbers: 160348 146643 147129 146630 147208 146972 153707 147378 146742 157650 146986 147098 157696 153946 146940 147144 147029 160384 153884 147009 153628 153706 146729 147155 153790 146896 153757 136503 147372 136345 153762 146883 160421 153195 146427 153834 135927 154157 135862 153998 153257 153220 153682 160341

    Distribution

    USA Distribution to the states of MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, NY, OH, PA and CO.

    Quantity

    44