BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy.

    Recall: Z-1957-2011 · Initiated February 7, 2011

    Recall

    Recall Number
    Z-1957-2011
    Event Number
    58072
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 7, 2011
    Posted
    April 12, 2011
    Terminated
    December 23, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy.

    Reason

    An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation.

    Action

    Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected customers on February 7, 2011.

    Distribution

    Worldwide Distribution.

    Quantity

    421