BEUDAMED
    FDA Recall 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 · Initiated March 7, 2016

    Recall

    Recall Number
    Z-1309-2016
    Event Number
    73550
    Firm
    Viewray Incorporated
    FEI Number
    3007546534
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 7, 2016
    Posted
    March 31, 2016
    Terminated
    February 22, 2017
    Address
    2 Thermo Fisher Way, Oakwood Village, OH, 44146-6536

    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.

    Action

    ViewRay sent an Urgent Device Correction letter dated March 7, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact ViewRay Customer Support at [email protected] or call the ViewRay Customer Support center at 855-286-8875.

    Distribution

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

    Quantity

    5 units