BEUDAMED
    FDA Recall Terminated

    SIEMENS AXIOM Artis - AUTOMAP FUNCTION

    Recall: Z-1108-04 · Initiated June 2, 2004

    Recall

    Recall Number
    Z-1108-04
    Event Number
    29327
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2004
    Posted
    July 20, 2004
    Terminated
    October 21, 2004
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    SIEMENS AXIOM Artis - AUTOMAP FUNCTION

    Reason

    Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash.

    Action

    The recalling firm sent recall letter to their customers informing them of the software problem. The customers were informed that a Siemens Service Representative will visit each location to deactivate Module 2 of the AUTOMAP function per Update AX023/04S.

    Distribution

    The recalled product has been distributed throughout the United States, such as: AK, AL, AZ, CA, DC, FL, GA, IA, IL, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI,

    Quantity

    127 units