BEUDAMED
    FDA Recall Terminated

    Axiom Aristos TX. Model number 58 94 873 Radiology system

    Recall: Z-0988-05 · Initiated June 10, 2005

    Recall

    Recall Number
    Z-0988-05
    Event Number
    32516
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 10, 2005
    Posted
    July 13, 2005
    Terminated
    August 30, 2006
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Axiom Aristos TX. Model number 58 94 873 Radiology system

    Reason

    potential issue (system may lock up) when repeating patient registrations

    Action

    The recalling firm issed a Customer Advisory Letter via certified mail to their cutomers informing them of the problem and information for the workaround to prevent problems for occurring until the software is upgraded.

    Distribution

    Nationwide. The products were shipped to hospitals in AZ, CA, CO, FL, GA, IL, IN, KS, KY, ME, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA, WA, and WI.

    Quantity

    72 units