BEUDAMED
    FDA Recall Terminated

    Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.

    Recall: Z-0860-2012 · Initiated December 12, 2011

    Recall

    Recall Number
    Z-0860-2012
    Event Number
    60789
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 12, 2011
    Posted
    January 25, 2012
    Terminated
    January 14, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.

    Reason

    Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type.

    Action

    Siemens Healthcare sent a "SAFETY ADVISORY NOTICE" dated December 12, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The firm prepared a modification, which will be provided to the affected customer under Update Instruction XP055/11/S. The firm will resolve this potential issue by preventively exchanging all bolts for the fixation of the X-ray tube holder of the concerned AXIOM Aristos FX Plus unit.

    Distribution

    Product distributed in one hospital in California.

    Quantity

    1