BEUDAMED
    FDA Recall Terminated

    4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator Varian Medical Systems, Palo Alto, CA. The 4DITC is designed to interface to the Varian Clinac Treatment Control System for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment.. The True Beam is a medical linear accelerator which delivers X-ray and electron radiation for sterotactic radiosurgery and therapeutic radiation.

    Recall: Z-0691-2012 · Initiated December 12, 2011

    Recall

    Recall Number
    Z-0691-2012
    Event Number
    60829
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 12, 2011
    Posted
    January 11, 2012
    Terminated
    July 26, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator Varian Medical Systems, Palo Alto, CA. The 4DITC is designed to interface to the Varian Clinac Treatment Control System for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment.. The True Beam is a medical linear accelerator which delivers X-ray and electron radiation for sterotactic radiosurgery and therapeutic radiation.

    Reason

    Varian has discovered that on 4D Integrated Treatment Console and TrueBeam, the ad-hoc CIAO(Complete Irradiated Area Outline) calculation results in the CIAO generation that is different from the CIAO in RT Chart. The 4DITC algorithm adds dose for the control point at field edge, which should not be added according to the system specifications.

    Action

    Varian Medical Systems sent a Urgent Medical Device Notice dated December 22, 2011, to all affected customers via certified mail. The letter identified the product the problem and the action needed to be taken by the customer. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the recall. ***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.*** Canadian account letters were sent by Fed Ex. International Customer Support Managers were sent letters for translation (when necessary) prior to sending to accounts. All of the information will be posted on the Varian web site and all appropriate personnel in the radiotherapy department should be advised of the content of this letter. A complete list of affected code numbers is included as well as contact information for Varian Oncology Help Desk. USA and Canada - 888-827-4265.

    Distribution

    Worldwide Distribution -- USA (nationwide)

    Quantity

    4875 units