BEUDAMED
    FDA Recall Terminated

    XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    Recall: Z-2593-2011 · Initiated May 27, 2010

    Recall

    Recall Number
    Z-2593-2011
    Event Number
    58262
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 27, 2010
    Posted
    June 20, 2011
    Terminated
    April 9, 2014
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    XiO Radiation Treatment Planning System, XiO Release 2.1.0 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: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a patient in Teletherapy, the user is prompted with Head/Foot Gantry on the text page. This prompt is asking for the orientation of the patient when they are treated.

    Action

    Computerized Medical Systems Inc sent an undated Safety Notice to all affected customers. The notice indicated the problem, the clinical impact, and the workaround. The notice stated the sites will be notified when a solution is available.

    Distribution

    Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, 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, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.

    Quantity

    1400