BEUDAMED
    FDA Recall Terminated

    TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.

    Recall: Z-1649-2011 · Initiated January 26, 2011

    Recall

    Recall Number
    Z-1649-2011
    Event Number
    57914
    Firm
    TomoTherapy Incorporated
    FEI Number
    3003873069
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 26, 2011
    Posted
    March 14, 2011
    Terminated
    March 18, 2014
    Address
    1240 Deming Way, Madison, WI, 53717

    Description

    TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.

    Reason

    It was determined that the Treatment Planning Station (TPS) can potentially under dose.

    Action

    Consignees were sent a TomoTherapy "Field Safety Notice Medical Device Correction" letter dated January 26, 2011. The letter was addressed to "TomoTherapy Customer". The letter described the Planning Issue, Related DQA Consideration, Graphical Presentation of Results, Product Affected, Recommended Action and Resolution. The letter suggests to use the information presented in order to avoid creating plans with an increased potential for discrepancies in planned vs. delivered dose. Specifically include measurements for small, off-axis targets that could be susceptible to the effects of this issue. DQA dose measurements should be performed at each unique full fraction dose that will be used for patient treatment, without using DQA scaling. If Customers have any questions they are to contact TomoTherapy Interaction Center by email or phone.

    Distribution

    Worldwide Distribution -- US, including 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, NV, NJ, NM, NY ,NC, ND,OH, OK OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of SPAIN, GERMANY, FRANCE, INDIA, KOREA, SWEDEN, ITALY, MALAYSIA, SWITZERLAND, CANADA, UNITED KINGDOM, SINGAPORE, TURKEY, TAIWAN, AUSTRALIA, JAPAN, BELGIUM, CHINA, MEXICO, NETHERLANDS, POLAND, SAUDI ARABIA, and UNITED ARAB EMIRATES.

    Quantity

    326