BEUDAMED
    FDA Recall Terminated

    Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system

    Recall: Z-1959-2011 · Initiated February 17, 2011

    Recall

    Recall Number
    Z-1959-2011
    Event Number
    58110
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 17, 2011
    Posted
    April 12, 2011
    Terminated
    July 16, 2013
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system

    Reason

    During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. If this occurs in vertical modes, the possibility exists that the detect

    Action

    The firm, SIEMENS, sent a "Safety Advisory Notice" dated February 15, 2011 to the affected customers via Update Instructions XP016/10/S on February 17, 2011. The notice described the product, problem and actions to be taken. The customers were instructed to immediately instruct their personnel accordingly; ensure that the safety advisory is placed in the systems's instructions for use; if they have sold this device/equipment and it is no longer in their possession, forward this safety notice to the new owner of the device/equipment; inform SIEMENS about the new owner of the device/equipment, and complete and return the Acknowledgement of receipt form. SIEMENS is preparing a modification of AXIOM Aristos FX and FX Plus that will resolve this potential malfunction. The field modification will be available from February 2011 and is expected to be carried out May 31, 2011. If you have any questions, call 09131-18-9908 or +1-888-826-9702.

    Distribution

    Nationwide Distribution: USA including states of: AZ, AK, CA, CO, FL, GA. IL, IN, IA, KS, KY, ME, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, and WI.

    Quantity

    101