BEUDAMED
    FDA Enforcement Class II Terminated

    Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are 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/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    Recall: Z-0972-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0972-2017
    Event ID
    76016
    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 18, 2017
    Initiation Date
    December 8, 2016
    Classification Date
    January 9, 2017
    Termination Date
    April 9, 2019
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are 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/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    Reason

    Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.

    Code Info

    Model # 10848280, 10848281, 10848282, 10848353, 10848354, 10848355

    Distribution

    Nationwide Distribution

    Quantity

    1,500 distributed Worldwide