BEUDAMED
    FDA Recall Terminated

    4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

    Recall: Z-2654-2014 · Initiated August 18, 2014

    Recall

    Recall Number
    Z-2654-2014
    Event Number
    69126
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 18, 2014
    Posted
    September 16, 2014
    Terminated
    July 30, 2015
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

    Reason

    Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.

    Action

    Varian issued an Urgent Medical Device Correction Notification letter dated August 19, 2014, to all affected sites. The letter informed users of the specific product and versions numbers as well as the issue. A list of third party systems that perform verification and communicate authorizations via ADI are included in Table 1 of the letter. The issue is only now to occur with the ExacTract positioning system in combination with a C-Series HE linac BCCV. User recommended actions are provided for users using auxiliary devices requiring ADI interface and for users performing SRS/SBRT. Varian has developed a fix for the issue and customer service representatives will be contacting all affected sites to schedule installation. A copy of the correction letter is to be kept with the most current labeling and all personnel who work in the radiotherapy department should be made aware of the content of the letter. The recall Return response form is to be completed and returned. Questions may be directed to 1-888-827-4265 for US and Canada. Contact information is also provided for other areas of the world.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Brazil, Canada, Chili, China, Columbia, Czech Republic, France, Georgia, Germany, hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Macau, Malaysia, Mexico, Netherland,s Portugal, Qutar, Russia, Singapore, Slovenia, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine and United Kingdom.

    Quantity

    512 affected devices