BEUDAMED
    FDA Enforcement Class II Terminated

    MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.

    Recall: Z-0806-2016 · Reported February 24, 2016

    Enforcement

    Recall Number
    Z-0806-2016
    Event ID
    73086
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2016
    Initiation Date
    December 24, 2015
    Classification Date
    February 12, 2016
    Termination Date
    February 22, 2017
    Address
    2 Thermo Fisher Way, Oakwood Village, OH, 44146-6536, United States

    Description

    MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.

    Reason

    The system loaded a completion fraction in the incorrect order after a treatment interruption.

    Code Info

    Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105

    Distribution

    US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.

    Quantity

    5 units