BEUDAMED
    FDA Recall Terminated

    Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan.

    Recall: Z-0164-2009 · Initiated June 2, 2008

    Recall

    Recall Number
    Z-0164-2009
    Event Number
    48661
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 2, 2008
    Posted
    October 22, 2008
    Terminated
    May 3, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan.

    Reason

    A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.

    Action

    Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.

    Distribution

    Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.

    Quantity

    18