BEUDAMED
    FDA Recall Terminated

    AXIOM Artis X-ray systems running software versions VB11K and VB22G

    Recall: Z-0809-06 · Initiated March 10, 2006

    Recall

    Recall Number
    Z-0809-06
    Event Number
    34881
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2006
    Posted
    April 26, 2006
    Terminated
    August 30, 2006
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    AXIOM Artis X-ray systems running software versions VB11K and VB22G

    Reason

    The recalling firm became aware of a potential problem when imaging patients on their stomach on the AXIOM Artis X-ray Systems running software versions VB11K and VB22G. In some instances, the orientation labels could be incorrect.

    Action

    The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions AX011/06/S and AX013/06/S, on 3/10/2006. This informs customers of the potential problem and provides a recommendation to avoid this issue.

    Distribution

    Nationwide. The product was shipped to medical facilities in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL,IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI and WV.

    Quantity

    287