BEUDAMED
    FDA Recall Terminated

    HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART 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 tissue. 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 physician approved plan.

    Recall: Z-3108-2011 · Initiated July 13, 2011

    Recall

    Recall Number
    Z-3108-2011
    Event Number
    59439
    Firm
    Accuray Incorporated
    FEI Number
    3003873069
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 13, 2011
    Posted
    August 31, 2011
    Terminated
    March 18, 2014
    Address
    1240 Deming Way, Madison, WI, 53717-1954

    Description

    HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART 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 tissue. 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 physician approved plan.

    Reason

    As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occu

    Action

    TomoTherapy sent a "Urgent Medical Device Correction" letter dated July 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This issue will be remedied with HiArt software version 4.1 and HD software version 1.1 and later. If you have any questions, please contact the TomoTherapy Technical Solutions Center by e-mail "[email protected]" . Please refer to the letter for what phone number you should call depending on where you are.

    Distribution

    Worldwide Distribution-- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and the countries United Arab Emirates United Kingdom Turkey Switzerland Sweden Spain Saudi Arabia Poland Netherlands Italy Germany France Belgium Taiwan Singapore Malaysia Korea Japan India Hong Kong China Australia Mexico El Salvador and Canada

    Quantity

    346