BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1202-2014 · Initiated December 5, 2013

    Recall

    Recall Number
    Z-1202-2014
    Event Number
    67016
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 5, 2013
    Posted
    March 27, 2014
    Terminated
    November 6, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    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).

    Action

    Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.

    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