BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HDXT TESLA SYSTEM

    MDR report key: 24381184 · Received February 18, 2026

    Report

    Report Number
    MW5184048
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 13, 2026
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC.
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MRI MACHINE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445851 GE HDXT TESLA SYSTEM SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown