BEUDAMED
    FDA Recall Terminated

    LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.

    Recall: Z-0978-2007 · Initiated March 9, 2007

    Recall

    Recall Number
    Z-0978-2007
    Event Number
    37803
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 9, 2007
    Posted
    June 28, 2007
    Terminated
    February 28, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1038

    Description

    LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.

    Reason

    A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation.

    Action

    The recalling firm notified medical device end users by letter dated 03/09/07 and advised of the software anomaly and provided details for user corrective action pending software upgrade by the manufacturer.

    Distribution

    The medical devices were distributed to medical centers nationwide and worldwide.

    Quantity

    80 devices