BEUDAMED
    FDA Recall Terminated

    Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (Brachytherapy) treatments.

    Recall: Z-3002-2011 · Initiated June 30, 2011

    Recall

    Recall Number
    Z-3002-2011
    Event Number
    59378
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 30, 2011
    Posted
    August 11, 2011
    Terminated
    May 9, 2014
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (Brachytherapy) treatments.

    Reason

    In affected Eclipse versions, the treatment field energy may change from the current selection to a previous selection without use intervention and without invalidating the MU or calculated dose distribution.

    Action

    Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 30, 2011 to all affected consignees. The letter identifies the affected product, problem, and actions to be taken. The letter states that Varian will contact all affected customers to apply a database configuration script to the database and is preparing a correction for Eclipse Version 10 to address the issue. A Varian representative will contact each site to schedule correction when it is available. The letter also provides RECOMMENDED USER ACTIONS to follow. The Letters go on to reiterate caution and warnings from Eclipse instructions for use. All appropriate personnel should be notified of the correction notice. For future reference, this document will be posted to the Varian customer support website: http://www.MyVarian.com. For further clarification, contact your local Varian Customer Support District or Regional Manager.

    Distribution

    Worldwide Distribution.

    Quantity

    2436