BEUDAMED
    FDA Recall Terminated

    XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Recall: Z-2579-2011 · Initiated October 3, 2010

    Recall

    Recall Number
    Z-2579-2011
    Event Number
    58197
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 3, 2010
    Posted
    June 16, 2011
    Terminated
    April 3, 2014
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Reason

    XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port

    Action

    The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 14, 2010 to its affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to distribute this notice to any all users of CMS software at their organization who are potentially affected by this issue, and complete and return the attached postcard to confirm receipt of the Safety Notice. The notice also states that this problem has existed since the XiO Release 4.3.0 and is resolved in the XiO release 4.26.00. Elekta will notify the customers when this solution is available. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.

    Distribution

    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, .Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.

    Quantity

    1208