BEUDAMED
    FDA Recall Terminated

    TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)

    Recall: Z-0507-2015 · Initiated November 21, 2014

    Recall

    Recall Number
    Z-0507-2015
    Event Number
    69854
    Firm
    TomoTherapy Incorporated
    FEI Number
    3003873069
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 21, 2014
    Posted
    December 12, 2014
    Terminated
    July 17, 2015
    Address
    1240 Deming Way, Madison, WI, 53717-1954

    Description

    TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)

    Reason

    Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.

    Action

    Accuray sent an "Urgent Field Safety Notice" dated November 21, 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customers. For questions they can contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solutions Center at www.accuray.com>Services & Support or call: North America: +1.877.668.8667, Europe: +800.4141.9595, Hong Kong: +852.2247.8688, Japan: +81.3.6269.9556. Requested consignees to complete and return the Acknowledgement Form to Accuray Regulatory Affairs.

    Distribution

    Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO, NE, NM, NY, NC, OK, OR, PA, SD, TN, TX, UT, WA, WV, WI and WY., and the countries of : JAPAN, BELGIUM, NETHERLANDS, ITALY, GERMANY, KOREA, FRANCE, SWITZERLAND, ENGLAND, CANADA, MEXICO, HONG KONG, AUSTRALIA, SRI LANKA, GREECE, CHINA, PHILIPPINES, MARTINIQUE, ROMANIA, SPAIN and TURKEY.

    Quantity

    210 ( 72 USA; 138 OUS )