BEUDAMED
    FDA Recall Terminated

    XiO Radiation Treatment Planning System, Release 4.51.00.

    Recall: Z-1209-2010 · Initiated February 22, 2010

    Recall

    Recall Number
    Z-1209-2010
    Event Number
    55008
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 22, 2010
    Posted
    March 25, 2010
    Terminated
    August 24, 2011
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    XiO Radiation Treatment Planning System, Release 4.51.00.

    Reason

    Inconsistent MLC positions, dose, and monitor units

    Action

    Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.

    Distribution

    Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.

    Quantity

    Planning system is loaded 25 in locations