BEUDAMED
    FDA Recall Terminated

    TomoTherapy Treatment System - Product Usage: 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.

    Recall: Z-0784-2021 · Initiated December 10, 2020

    Recall

    Recall Number
    Z-0784-2021
    Event Number
    86993
    Firm
    Accuray Incorporated
    FEI Number
    3003873069
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    December 10, 2020
    Terminated
    September 26, 2022
    Address
    1240 Deming Way, Madison, WI, 53717-1954

    Description

    TomoTherapy Treatment System - Product Usage: 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.

    Reason

    "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

    Action

    Urgent Medical Device Recall "MLC tickle error" issue during TomoHelical deliver was sent to customers beginning 12/10/2020. Accuray is planning software releases that will address this issue. All TomoTherapy systems at affected software versions will be upgraded to these versions once released.

    Distribution

    Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.

    Quantity

    7 units