BEUDAMED
    FDA Recall Terminated

    TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.

    Recall: Z-2766-2011 · Initiated May 19, 2011

    Recall

    Recall Number
    Z-2766-2011
    Event Number
    58994
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 19, 2011
    Posted
    July 8, 2011
    Terminated
    March 13, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.

    Reason

    Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.

    Action

    Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 19, 2011, via certified mail, return receipt requested in the US. The letter identified the product, problem and recommended actions to be taken. For additional information contact Varian Customer Support at 1-888- 827-4265.

    Distribution

    Worldwide Distribution -- USA (nationwide) and countries of: Canada, Denmark, France, Germany, Isreal, Italy, Netherlands, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

    Quantity

    77