BEUDAMED
    FDA Recall Terminated

    XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Recall: Z-2408-2011 · Initiated September 10, 2010

    Recall

    Recall Number
    Z-2408-2011
    Event Number
    58205
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    muj
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 10, 2010
    Posted
    June 3, 2011
    Terminated
    April 8, 2014
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Reason

    When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate.

    Action

    Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice. For questions regarding this recall call 408-830-8000.

    Distribution

    Worldwide Distribution - USA (nationwide and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, 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, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.

    Quantity

    1377