BEUDAMED
    FDA Recall Terminated

    Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51; Reference/PSCA Identifier: CP-03940; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.

    Recall: Z-3098-2011 · Initiated June 23, 2011

    Recall

    Recall Number
    Z-3098-2011
    Event Number
    59350
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 23, 2011
    Posted
    August 31, 2011
    Terminated
    March 15, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51; Reference/PSCA Identifier: CP-03940; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.

    Reason

    Varian has scheduled for an upgrade of the device from current version to 10.2. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history information.

    Action

    Varian Medical Systems, Inc. sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 23, 2011 to all affected customers. The letter identified the product, problem and recommended user actions to follow. Customers were instructed to notify all appropriate personnel of the correction notice. The letter states that the recalling firm will issue a Customer Technical bulletin to inform users of the mandatory upgrade and related information. For future reference, this document will be posted to the Varian customer support website: http://www.MyVarian.com. Any questions regarding this Product Notification letter, contact Varian Medical Systems Help desk at 1-888-827-4265 for USA and Canada and +41417498844 for Europe.

    Distribution

    Worldwide Distribution - USA (nationwide)