BEUDAMED
    FDA Recall Terminated

    MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.

    Recall: Z-0806-2016 · Initiated December 24, 2015

    Recall

    Recall Number
    Z-0806-2016
    Event Number
    73086
    Firm
    Viewray Incorporated
    FEI Number
    3007546534
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 24, 2015
    Posted
    February 12, 2016
    Terminated
    February 22, 2017
    Address
    2 Thermo Fisher Way, Oakwood Village, OH, 44146-6536

    Description

    MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.

    Reason

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

    Action

    ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at [email protected] or call the ViewRay" Customer Support center at 855-286- 8875.

    Distribution

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

    Quantity

    5 units