Sonio Detect AI ultrasound software mislabels fetal structures in prenatal imaging
Sonio Detect AI mislabels fetal anatomy in prenatal ultrasound, with a MAUDE adverse event entry and Reuters reporting; Samsung Medison says the FDA report does not indicate a safety issue and no action was requested.
Sonio detect software ai algorithm is faulty and wrongly labels fetal structures and associates them with the wrong body parts.
Key facts
- What
- Sonio Detect AI mislabels fetal anatomy in prenatal ultrasound, with a MAUDE adverse event entry and Reuters reporting; Samsung Medison says the FDA report does not indicate a safety issue and no action was requested.
- Incident date
- Jun 1, 2025
- Who
- Samsung Medison (Sonio SAS)
- Failure mode
- Hallucination
- AI surface
- Copilot
- Severity
- High
What happened
Sonio Detect AI ultrasound software allegedly misidentified fetal anatomical structures and mapped them to incorrect body parts during prenatal imaging. These errors were reported to the FDA in June 2025. Samsung Medison stated that the FDA report did not indicate any safety issue and that no action had been requested by the regulator.
What broke inside the model
- 01 · TriggerA user asks for a fact, a citation, or a figure.
- 02 · Model stepThe model writes a fluent, confident answer.
- 03 · Control gapNothing ties the claim back to a real source.
- 04 · FailureA fabricated fact ships as if it were verified.
- 05 · ConsequenceThe false claim reaches a customer, a court, or the public.
Confidence holds, and even spikes, as the claim detaches from any source.
The failure occurred within the AI's anatomical structure detection algorithm, leading to incorrect labeling of fetal structures and mapping to wrong body parts during prenatal imaging.
What it cost
Sources
- PressAs AI enters the operating room, reports arise of botched surgeries misidentified body partsreuters.com
- PrimaryMAUDE Adverse Event Report: SONIO SONIO DETECTaccessdata.fda.gov
Cite this entry
https://failureindex.ai/failures/sonio-detect-ultrasound-software-mislabels-fetalAI Failure Index. "Sonio Detect AI ultrasound software mislabels fetal structures in prenatal imaging" (FI-0259). Realm Labs. https://failureindex.ai/failures/sonio-detect-ultrasound-software-mislabels-fetal (indexed Jun 5, 2026).Data fields CC-BY 4.0, prose citation permitted. Incident ID FI-0259. Full dataset at /data.
Note from Realm Labs, the Index steward
How Realm would have caught this
- Prism
- OmniGuard
- AI Detection & Response (AIDR)
A runtime layer that watches the model's internal state can flag the moment a model commits to a claim it has no support for, and hold or reroute the response before it reaches a user. Realm reads those signals in real time rather than grading the transcript after the fact.