BEUDAMED
    FDA Recall Terminated

    Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.

    Recall: Z-2599-2011 · Initiated February 6, 2009

    Recall

    Recall Number
    Z-2599-2011
    Event Number
    58250
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 6, 2009
    Posted
    June 20, 2011
    Terminated
    April 8, 2014
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.

    Reason

    Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to

    Action

    Elekta CMS Software sent an "ADVISORY NOTICE" dated February 6, 2009 to its affected customers. The notice identified the product, the problem, and the actions to be taken. Customers were informed that the workaround method available is to (edit the MLC pattern using the aperture first and the individual MLC leaf edits second). The firm states that this issue will be resolved in Focal version 4.50.00 and above. A "User Notice" will be sent to all users still using the affected software notifying them of the updated software available to correct the problem. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.

    Distribution

    Worldwide Distribution -- USA (nationwide) including the state of: Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, Uruguay and Venezuela.

    Quantity

    760