BEUDAMED
    FDA Enforcement Class II 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 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1954-2015
    Event ID
    71505
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    May 7, 2015
    Classification Date
    July 2, 2015
    Termination Date
    February 4, 2016
    Address
    2 Thermo Fisher Way, Oakwood Village, OH, 44146-6536, United States

    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.

    Code Info

    Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102

    Distribution

    Distributed in the states of CA, MO & WI.

    Quantity

    3