BEUDAMED
    FDA Recall Terminated

    Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48

    Recall: Z-1612-2008 · Initiated February 13, 2008

    Recall

    Recall Number
    Z-1612-2008
    Event Number
    46902
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 13, 2008
    Posted
    September 23, 2008
    Terminated
    May 17, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48

    Reason

    A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.

    Distribution

    Product was distributed throughout the USA (in LA, IN, GA, MD, IL, AR, CA, MA, FL, AZ, SC, MO, CO, AL, OK, WA, MI, IN, NY, TX, MS, NE, TN, VA, WI, OR, DC, and NC) and internationally (Japan, Columbia, Canada, India, Czech Republic, Turkey, Germany, Portugal, Venezuela, Australia, South Korea).

    Quantity

    90 units