BEUDAMED
    FDA Recall Terminated

    XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Recall: Z-2567-2011 · Initiated December 9, 2008

    Recall

    Recall Number
    Z-2567-2011
    Event Number
    58227
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 9, 2008
    Posted
    June 15, 2011
    Terminated
    April 9, 2014
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Reason

    XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re

    Action

    Computerized Medical Systems, Inc. sent a "XiO CUSTOMER ADVISORY" letter dated December 8, 2008 to all affected customers. The advisory describes the product, problem, and the actions to be taken. The customers were instructed to set the prompt to "Yes" to avoid the problem from occurring according to written instructions provided in the advisory. This problem has existed since Release 4.3.1 and is expected to be resolved with XiO Release 4.50.00. Questions should be directed to the manufacturer's representative at 408-830-8023.

    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, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Tajikistan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.

    Quantity

    784