BEUDAMED
    FDA Recall Terminated

    Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-1954-2015 · Initiated May 7, 2015

    Recall

    Recall Number
    Z-1954-2015
    Event Number
    71505
    Firm
    Viewray Incorporated
    FEI Number
    3007546534
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 7, 2015
    Posted
    July 2, 2015
    Terminated
    February 4, 2016
    Address
    2 Thermo Fisher Way, Oakwood Village, OH, 44146-6536

    Description

    Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    The software was failing to determine new patient locations if imaging is not enabled during treatment.

    Action

    On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers.

    Distribution

    Distributed in the states of CA, MO & WI.

    Quantity

    3