BEUDAMED
    FDA Enforcement Class II Terminated

    MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated

    Recall: Z-1309-2016 · Reported April 6, 2016

    Enforcement

    Recall Number
    Z-1309-2016
    Event ID
    73550
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 6, 2016
    Initiation Date
    March 7, 2016
    Classification Date
    March 31, 2016
    Termination Date
    February 22, 2017
    Address
    2 Thermo Fisher Way, N/A, Oakwood Village, OH, 44146-6536, United States

    Description

    MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated

    Reason

    When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.

    Code Info

    Model number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100, 101, 102, 104 & 105

    Distribution

    Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.

    Quantity

    5 units