BEUDAMED
    FDA Enforcement Class II Terminated

    ViewRay System, Radiation Therapy System

    Recall: Z-1580-2015 · Reported May 13, 2015

    Enforcement

    Recall Number
    Z-1580-2015
    Event ID
    71050
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 13, 2015
    Initiation Date
    January 15, 2015
    Classification Date
    May 5, 2015
    Termination Date
    September 23, 2015
    Address
    2 Thermo Fisher Way, N/A, Oakwood Village, OH, 44146-6536, United States

    Description

    ViewRay System, Radiation Therapy System

    Reason

    The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.

    Code Info

    M/N 10000, S/N 100 only

    Distribution

    US distribution to MO.

    Quantity

    1