BEUDAMED
    FDA Recall Terminated

    Linear accelerator workstation software suite

    Recall: Z-1084-04 · Initiated May 27, 2004

    Recall

    Recall Number
    Z-1084-04
    Event Number
    29338
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 27, 2004
    Posted
    July 20, 2004
    Terminated
    December 20, 2004
    Address
    3100 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Linear accelerator workstation software suite

    Reason

    An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1

    Action

    Varian will notify customers via phone beginning 5/27/2004 and distribute a product notification letters June 3, 2004, notifying them of the anomaly and corrective action, and finally, the anomaly will be corrected by a future release of software.

    Distribution

    units were distributed throughout the US and Canada, as well as approximately 66 other foreign consignees, including

    Quantity

    155 units