BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray

    Recall: Z-1202-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1202-2014
    Event ID
    67016
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2014
    Initiation Date
    December 5, 2013
    Classification Date
    March 27, 2014
    Termination Date
    November 6, 2014
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray

    Reason

    There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).

    Code Info

    model numbers 10848280, 10848281, 10848282, and 10848283.

    Distribution

    USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.

    Quantity

    19