BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.

    Recall: Z-0861-2009 · Initiated November 21, 2008

    Recall

    Recall Number
    Z-0861-2009
    Event Number
    50496
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 21, 2008
    Posted
    February 20, 2009
    Terminated
    March 10, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.

    Reason

    Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded.

    Action

    An Urgent Device Correction product notification letter/field safetly letter dated November 21, 2008, was distributed to all affected users, with a description of the problem and user corrective action steps. The letter was also distributed to Varian Sales, Marketing and Service organizations, informing them of the issue.

    Distribution

    Worldwide Distribution: USA, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Lithuania, Norway, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Netherlands, Turkey and the United Kingdom.

    Quantity

    516 units