BEUDAMED
    FDA Recall Terminated

    Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) Varian Medical Systems, Inc. Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradiation with photon, electron and proton beams, as well as for internal radiation treatments.

    Recall: Z-2780-2011 · Initiated May 13, 2011

    Recall

    Recall Number
    Z-2780-2011
    Event Number
    58969
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 13, 2011
    Posted
    July 11, 2011
    Terminated
    August 15, 2014
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) Varian Medical Systems, Inc. Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradiation with photon, electron and proton beams, as well as for internal radiation treatments.

    Reason

    In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions.

    Action

    Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter included the description of the product, problem and recommendations and includes the release of a service pack in the future. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)

    Distribution

    Worldwide distribution: Nationwide (USA) and the country of Canada.

    Quantity

    10,097***12-12-12 AMENDED TO: 10664 units***