BEUDAMED
    FDA Recall Terminated

    Axiom Artis Systems operating with A100 Generator

    Recall: Z-1237-2010 · Initiated March 4, 2010

    Recall

    Recall Number
    Z-1237-2010
    Event Number
    54999
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 4, 2010
    Posted
    April 5, 2010
    Terminated
    July 5, 2012
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Axiom Artis Systems operating with A100 Generator

    Reason

    Due to a contact problem at the low voltage power supply of the generator controller, in rare cases where a user has invoked radiation, it may occur that no radiation is released. Under certain circumstances, radiation is possible by repeated release of the x-ray footswitch or button. To remedy the issue described above, a revised cabling has been installed in all potentially affected syste

    Action

    The recalling firm issued a Customer Safety Advisory to affected customers via Update Instructions AX006/10/S. The letter informs customers of the potential issues and provides additional information on the implemented resolutions. For additional information, please contact the firm at 888-826-9702.

    Distribution

    The product was shipped to medical facilities nationwide.

    Quantity

    1373 units