BEUDAMED
    FDA Recall Terminated

    On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields relation to anatomical and/or fiducial landmarks. Trilogy Mx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    Recall: Z-3101-2011 · Initiated June 21, 2011

    Recall

    Recall Number
    Z-3101-2011
    Event Number
    59262
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 21, 2011
    Posted
    August 31, 2011
    Terminated
    March 15, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields relation to anatomical and/or fiducial landmarks. Trilogy Mx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    Reason

    Varian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s.

    Action

    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 21, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. ***12-20-12, 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 recommends several user actions. The firm is developing a correction for the issue and will contact customers when the correction is available. Questions regarding this notice may be addressed by contacting the Varian Oncology Help Desk at 1-888-827-4265.

    Distribution

    Worldwide Distribution

    Quantity

    2268