BEUDAMED
    FDA Recall Terminated

    XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Recall: Z-2578-2011 · Initiated September 17, 2010

    Recall

    Recall Number
    Z-2578-2011
    Event Number
    58200
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 17, 2010
    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 4.2.0 and above Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Reason

    When a dialog box is displayed and the dose status is changed to "Dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). Then if CANCEL is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with t

    Action

    The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 6, 2010 to its affected customers. The notice describes the product, problem and actions to be taken (workaround). The customers were instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. The notice also states that this problem has existed since XiO Release 4.2.0 and will be resolved in XiO Release 4.70.00. Elekta will notify the sites 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, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, 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, 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, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.

    Quantity

    1293