BEUDAMED
    FDA Recall Terminated

    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    Recall: Z-2240-2014 · Initiated July 16, 2014

    Recall

    Recall Number
    Z-2240-2014
    Event Number
    68960
    Firm
    TomoTherapy Incorporated
    FEI Number
    3003873069
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 16, 2014
    Posted
    August 15, 2014
    Terminated
    July 21, 2015
    Address
    1240 Deming Way, Madison, WI, 53717-1954

    Description

    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    Reason

    Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.

    Action

    Accuray sent an "Urgent Device Correction" letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. These anomalies will be corrected with a new software version. You will be contacted by Accuray Customer Support to schedule a software upgrade to your system. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1.877.668.8667 (USA) or +1.408.716.4700 (non-USA) or [email protected].

    Distribution

    Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA, BELGIUM, CANADA, CHINA, ENGLAND, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, PHILIPPINES, RUSSIA, SPAIN, TAIWAN, TURKEY, MARTINIQUE, ROMANIA, SRI LANKA and SWITZERLAND.

    Quantity

    168 (75 US; 93 OUS)