MalfunctionQIH

SONIO DETECT

Received Jun 25, 2025

Report MW5171987 · MDR key 22340256

Device

Generic name

Automated Radiological Image Processing Software

Manufacturer

Sonio

Product problems

Computer Software Problem
Display or Visual Feedback Problem
Wrong Label

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.