BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 23256304 · Received October 9, 2025

    Report

    Report Number
    3004455125-2025-00002
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BARCO NV
    Product Code
    LLZ
    PMA / PMN Number
    K133663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (B)(6). WE HAVE BEEN INFORMED ABOUT A REPORT FROM A HOSPITAL IN (B)(6), IN WHICH A PHYSICIAN ASSERTS THAT THERE WAS A RISK OF MISDIAGNOSIS WHEN REVIEWING NUCLEAR MEDICINE (NM) MEDICAL IMAGES. INVESTIGATIONS HAVE CONCLUDED THAT THIS WAS CAUSED BY AN INCORRECT COLOR SETTING OF THE DISPLAY. THERE WERE NO REPORTS OF ACTUAL CONFIRMED MISDIAGNOSIS OR ANY HARM TO ANY PATIENT BECAUSE OF THIS SITUATION. THERE WAS NO MALFUNCTION OF THE DISPLAY ITSELF.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED ABOUT A REPORT FROM A HOSPITAL IN (B)(6), IN WHICH A PHYSICIAN ASSERTS THAT THERE WAS A RISK OF MISDIAGNOSIS WHEN REVIEWING NUCLEAR MEDICINE (NM) MEDICAL IMAGES. INVESTIGATIONS HAVE CONCLUDED THAT THIS WAS CAUSED BY AN INCORRECT COLOR SETTING OF THE DISPLAY. THERE WERE NO REPORTS OF ACTUAL CONFIRMED MISDIAGNOSIS OR ANY HARM TO ANY PATIENT BECAUSE OF THIS SITUATION. THERE WAS NO MALFUNCTION OF THE DISPLAY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609750 BARCO DIAGNOSTIC DISPLAY LLZ BARCO NV MDNC-2221 MKII

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown