BEUDAMED
    FDA Recall Terminated

    ARTIS Q, Interventional Fluroscopic x-ray system

    Recall: Z-1534-2017 · Initiated February 22, 2017

    Recall

    Recall Number
    Z-1534-2017
    Event Number
    76713
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 22, 2017
    Posted
    March 19, 2017
    Terminated
    October 24, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ARTIS Q, Interventional Fluroscopic x-ray system

    Reason

    In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.

    Action

    A Customer Safety Advisory Notice (CSAN) was mailed on 02/22/2017 to customers affected by the issue on 02/22/2017 to inform them of the corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the impact on system operation and the potential risk to patients. It also informed users of the actions being taken and how they will be implemented.

    Distribution

    Distributed throughout the United States.

    Quantity

    264 distributed worldwide (112 in the U.S.)