BEUDAMED
    FDA Recall Terminated

    Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.

    Recall: Z-0552-2014 · Initiated November 18, 2013

    Recall

    Recall Number
    Z-0552-2014
    Event Number
    66956
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 18, 2013
    Posted
    December 20, 2013
    Terminated
    March 13, 2015
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.

    Reason

    An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.

    Action

    Varian Medical Systems will provide all affected consignees with an Urgent Medical Device Correction Letter commencing on November 18, 2013 by federal express. . The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the reported issue.

    Distribution

    Worldwide Distribution.

    Quantity

    6701