BEUDAMED
    FDA Recall Terminated

    XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Recall: Z-2577-2011 · Initiated April 8, 2008

    Recall

    Recall Number
    Z-2577-2011
    Event Number
    58210
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 8, 2008
    Posted
    June 16, 2011
    Terminated
    April 8, 2014
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Reason

    XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are not correct.

    Action

    The firm, CMS, Inc., sent a "XiO Customer Advisory" letter dated April 8, 2008 to all affected customers. The letter describes the product, the problem, and the actions to be taken ( workaround). The letter also states the problem will be resolved in a future release. No release number or date was given. If you have any questions, please call 408-380-8023.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: China, France, Germany, Japan, Mongolia, Netherlands, Nicaragua, Poland, Russia, South Korea, Switzerland, and Turkey.

    Quantity

    75