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 of brachytherapy has been prescribed.

    Recall: Z-2582-2011 · Initiated November 16, 2010

    Recall

    Recall Number
    Z-2582-2011
    Event Number
    57807
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 16, 2010
    Posted
    June 17, 2011
    Terminated
    April 3, 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 of brachytherapy has been prescribed.

    Reason

    XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculati

    Action

    Elekta CMS Software drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was distributed to all affected sites in November 2010. The issue will be resolved in the XiO Release 4.70.00, expected to be available in July 2011.

    Distribution

    Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria, Australia, Austria, Bahamas, Belarus, Belgium, Brazil, Canada, Chile, China,Croatia, Cyrus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Phillipines,Poland, Portugal, Romoania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, Turmenistan, Ukraine, United Kingdom, and Vietnam

    Quantity

    556