BEUDAMED
    FDA Enforcement Class II Terminated

    TomoTherapy Treatment Delivery System with iDMS - 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-0785-2021 · Reported January 13, 2021

    Enforcement

    Recall Number
    Z-0785-2021
    Event ID
    86993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Accuray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2021
    Initiation Date
    December 10, 2020
    Classification Date
    January 7, 2021
    Termination Date
    September 26, 2022
    Address
    1240 Deming Way, Madison, WI, 53717-1954, United States

    Description

    TomoTherapy Treatment Delivery System with iDMS - 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.

    Code Info

    Product Codes: 104430, 1018286, H-0000-0003, 1018283. System Version: 1.2 (also referred to as 5.6.2). Serial Numbers: 110105, 110219, 110221, 110267, 110284, 110290, 110308, 110368,

    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

    8 units