BEUDAMED
    FDA Recall Terminated

    Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Palo Alto, CA. Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye.

    Recall: Z-1161-2012 · Initiated January 30, 2012

    Recall

    Recall Number
    Z-1161-2012
    Event Number
    61198
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 30, 2012
    Posted
    March 6, 2012
    Terminated
    August 15, 2014
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Palo Alto, CA. Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye.

    Reason

    Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open.

    Action

    Varian sent an URGENT MEDICAL DEVICE CORRECTION - URGENT FIELD SAFETY NOTICE letter dated January 30, 2012 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 identified the affected product, description of problem, provide recommended user actions, and special instructions for customers outside the USA and Canada. The letter stated that this document will be posted on the customer support website: http://www.MyVarian.com. Customers were instructed to complete the attached Proof of Notification or Receipt Verification Card and return to Varian Medical Systems. For further clarification and questions contact your Varian Customer Support District or Regional Manager.

    Distribution

    Worldwide Distribution - (USA) Nationwide.

    Quantity

    12,077 units ***AMENDED TO 13,527 units***