BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIEWRAY MRIIDAN

    MDR report key: 18384317 · Received December 21, 2023

    Report

    Report Number
    MW5149480
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    October 25, 2023
    Report Date
    December 20, 2023
    Manufacturer
    VIEWRAY INCORPORATED
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SUPPORT FOR THE VIEWRAY ENDS ABRUPTLY AND SERVICE IS NO LONGER AVAILABLE EFFECTIVE OCTOBER 25, 2023 ALL OPERATIONS WOULD CEASE, AND CUSTOMERS THAT HAD PURCHASED THE $6 MILLION MRI/LINEAR ACCELERATOR, AND OFTEN SPENT MILLIONS MORE TO BUILD THE ROOM/VAULT TO HOUSE IT, WOULD NO LONGER BE ABLE TO USE OR SUPPORT IT, MUCH LESS TREAT CANCER PATIENTS WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263968 VIEWRAY MRIIDAN ACCELERATOR, LINEAR, MEDICAL IYE VIEWRAY INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other