BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOSAIQ

    MDR report key: 20686812 · Received November 13, 2024

    Report

    Report Number
    MW5162509
    Event Type
    Other
    Date Received
    November 13, 2024
    Date of Event
    November 7, 2024
    Report Date
    November 8, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    VENDOR IS PERFORMING AN UPGRADE TO THEIR SOFTWARE AND SERVICES, HOWEVER IT STILL ONLY SUPPORTS TLS1.0. THEIR PLAN TO GO TO TLS1.2 OR NEWER IS 1 1/2 TO 2 YEARS OUT. TLS 1.0 IS A DEPRECATED VERSION SINCE 2018 AND THEY HAVE NO PLAN TO CORRECT IN THE NEAR FUTURE. THIS IS THE RESPONSE FROM THE VENDOR: TLS 1.0 IS LIMITED TO SPECIFIC FUNCTIONALITY BETWEEN THE SERVER AND DATABASE. ALL APPLICABLE TRAFFIC IS INTERNAL TO ADVOCATE HEALTH. ANY/ALL DATA CONNECTIONS LEAVING ADVOCATE SUPPORTS TLS 1.2+. THERE IS ACTIVE DEVELOPMENT UNDERWAY THOUGH PATCH RELEASE IS NOT IMMINENT (1.5 TO 2 YEARS) A MAJOR UPGRADE/REVISION/REWRITE OF THE PRODUCT IS ALSO UNDERWAY WITH CYBERSECURITY IN MIND FROM BEGINNING. (ALSO 2 YEARS) EVEN WITH THE TLS 1.0 BEING INTERNAL, IF A THREAT ACTOR WAS ALREADY ON OUR NETWORK THEY COULD ACCESS THIS DATA. THEIR INTERIM SOLUTION AND COMPENSATING CONTROL COULD BE INSTALLED. THEY SUPPORT AN ADD-ON TLS WRAPPER TO CREATE VIRTUAL NIC CARDS THAT TUNNEL THE TRAFFIC. THIS IS TEMPORARY AND CANNOT BE IN PLACE FOR 1 1/2 TO 2 YEARS. WE NEED A LONG-TERM PLAN OF REMEDIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112755 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown