BEUDAMED
    FDA Recall Terminated

    XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Recall: Z-2407-2011 · Initiated May 27, 2010

    Recall

    Recall Number
    Z-2407-2011
    Event Number
    58267
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 27, 2010
    Posted
    June 2, 2011
    Terminated
    April 10, 2014
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Reason

    XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO.

    Action

    The firm, Elekta, issued an "important Safety Notice" undated, to its customers. The notice indicates the problem and the clinical impact. There is no reasonable workaround for this issue. The notice states a future XiO Release will resolve the issue and the customers will be notified when this solution is available. A return postcard was included with the mailing to verify consignee received the notice. For sites not returning the postcard within one month, the recalling firm will contact them via phone or email to confirm receipt of the notice. The customers were instructed to distribute this notice to any and all users of the CMS software at their organization who are potentially affected by this issue. If you have any questions, please call 314-993-0003 or 800-878-4267.

    Distribution

    Nationwide distribution, including Puerto Rico, to medical facilities. Distribution was also made to Military and Government consignees. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, and United Kingdom.

    Quantity

    415