BEUDAMED
    FDA Enforcement Class II Terminated

    ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software

    Recall: Z-1803-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1803-2020
    Event ID
    85441
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    November 18, 2019
    Classification Date
    April 27, 2020
    Termination Date
    February 22, 2023
    Address
    815 E Middlefield Rd, N/A, Mountain View, CA, 94043-4025, United States

    Description

    ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software

    Reason

    Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.

    Code Info

    Model No.10000 - Serial No's:. 100,104,105,112,113 Model No. 20000 - Serial No's: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250

    Distribution

    Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to them and they forwarded them to the sites.

    Quantity

    32