BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.

    Recall: Z-2231-2009 · Initiated July 17, 2009

    Recall

    Recall Number
    Z-2231-2009
    Event Number
    53045
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 17, 2009
    Posted
    September 22, 2009
    Terminated
    November 27, 2010
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.

    Reason

    Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.

    Action

    Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.

    Distribution

    Product was distributed to one user in Texas

    Quantity

    1