BEUDAMED
    FDA Recall Terminated

    Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA

    Recall: Z-0720-2008 · Initiated October 2, 2007

    Recall

    Recall Number
    Z-0720-2008
    Event Number
    45527
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 2, 2007
    Posted
    February 15, 2008
    Terminated
    May 17, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304

    Description

    Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA

    Reason

    Incorrect Software Validation- The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.

    Action

    An Urgent Medical Device Correction letter was distributed October 2, 2007, to all direct consignees, informing them that the ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery will not be recognized properly by the System. The firm provided corrective instructions and informed consignees that a product modification will be developed to resolve the issue. A Varian Service Representative will be scheduling a visit to upgrade the application.

    Distribution

    Worldwide Distribution