BEUDAMED
    FDA Recall Terminated

    ViewRay System, Radiation Therapy System

    Recall: Z-1580-2015 · Initiated January 15, 2015

    Recall

    Recall Number
    Z-1580-2015
    Event Number
    71050
    Firm
    Viewray Incorporated
    FEI Number
    3007546534
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    January 15, 2015
    Posted
    May 5, 2015
    Terminated
    September 23, 2015
    Address
    2 Thermo Fisher Way, Oakwood Village, OH, 44146-6536

    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.

    Action

    On January 15, 2014, ViewRay personnel discussed the investigation of the issue (slice mismatch error) with the customer. The firm advised the customer that until the issue was corrected, to not treat patients in non HFS orientations, or to use the MR acquired from the ViewRay system as the primary plan series for non HFS scans. ViewRay installed software version 3.4.5.28 on January 20 and 21, 2014, in order to prevent this slice mismatch error from occurring in any patient position.

    Distribution

    US distribution to MO.

    Quantity

    1