BEUDAMED
    FDA Enforcement Class II Terminated

    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-0115-2016 · Reported October 21, 2015

    Enforcement

    Recall Number
    Z-0115-2016
    Event ID
    72166
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 21, 2015
    Initiation Date
    August 27, 2015
    Classification Date
    October 9, 2015
    Termination Date
    June 9, 2017
    Address
    2 Thermo Fisher Way, N/A, Oakwood Village, OH, 44146-6536, United States

    Description

    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

    Code Info

    Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105

    Distribution

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

    Quantity

    4 units