BEUDAMED
    FDA Recall Terminated

    Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he 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/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    Recall: Z-0286-2018 · Initiated November 17, 2017

    Recall

    Recall Number
    Z-0286-2018
    Event Number
    78686
    Firm
    Accuray Incorporated
    FEI Number
    3003873069
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 17, 2017
    Terminated
    July 25, 2021
    Address
    1240 Deming Way, Madison, WI, 53717-1954

    Description

    Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he 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/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    Reason

    Uncontrolled couch Z-axis movement (descent)

    Action

    Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated the following: "Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series software version 2.1.2 (Hi Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem." For questions contact Accuray Customer Support by phoning the regional support lines.

    Distribution

    Worldwide Distribution

    Quantity

    250 units