BEUDAMED
    FDA Enforcement Class II Terminated

    Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-2085-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2085-2015
    Event ID
    71555
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    April 1, 2015
    Classification Date
    July 16, 2015
    Termination Date
    February 4, 2016
    Address
    2 Thermo Fisher Way, N/A, Oakwood Village, OH, 44146-6536, United States

    Description

    Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.

    Code Info

    Model #10000, Serial #'s: 100, 101, and 102

    Distribution

    US Nationwide Distribution in the states of CA, MO & WI

    Quantity

    3