BEUDAMED
    FDA Recall Terminated

    Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA

    Recall: Z-0821-2011 · Initiated July 20, 2010

    Recall

    Recall Number
    Z-0821-2011
    Event Number
    56774
    Firm
    Varian Medical Systems Inc.
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 20, 2010
    Posted
    December 28, 2010
    Terminated
    July 18, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA

    Reason

    The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option.

    Action

    Varian issued Urgent Medical Device Correction letters dated July 20, 2010 to its direct consignees, informing them of the affected product and providing instructions on the actions to be taken. These instruction include: if the unit does not display "RapidArc" or "VMAT" under Treatment Type during dose delivery, discontinue use of the device and call Varian service. Varian Service Help Desk can be contacted at 1-888-827-4265.

    Distribution

    Worldwide Distributiuon: Throughout the US, and the countries of Australia, Canada, China, Japan, and New Zealand, and in the regions of North and Latin America, Europe, and South East Asia.