BEUDAMED
    FDA Enforcement Class II Terminated

    Artis zee,x-ray system, angiographic Artis zee is a family of 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 with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis

    Recall: Z-2686-2017 · Reported July 26, 2017

    Enforcement

    Recall Number
    Z-2686-2017
    Event ID
    77201
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2017
    Initiation Date
    February 3, 2017
    Classification Date
    July 14, 2017
    Termination Date
    October 24, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Artis zee,x-ray system, angiographic Artis zee is a family of 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 with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis

    Reason

    Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.

    Code Info

    Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035

    Distribution

    Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY

    Quantity

    97 distributed worldwide, 12 distributed in United States