BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONIO DETECT

    MDR report key: 22340256 · Received June 25, 2025

    Report

    Report Number
    MW5171987
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Report Date
    June 18, 2025
    Manufacturer
    SONIO
    Product Code
    QIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    505
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SONIO DETECT SOFTWARE AI ALGORITHM IS FAULTY AND WRONGLY LABELS FETAL STRUCTURES AND ASSOCIATES THEM WITH THE WRONG BODY PARTS. THE SYSTEM WILL FREQUENTLY DISPLAY AS VISUALIZED EVEN THOUGH IT HASN'T LEAVING PROVIDERS TO GIVE FALSE NORMALCY AND OPENING THEM UP TO LIABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003580 SONIO DETECT AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE QIH SONIO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other