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Sonio Detect

SONIO · Model 2 · UDI-DI 03770024341041

IYN IYO QIH

510(k) clearances

2,748

Adverse events (35 deaths)

300

Recalls

220

Facilities

Description

Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol. Sonio Detect receives fetal ultrasound images and clips from the ultrasound machine, that are submitted through the edge software by the performing healthcare professional, in real-time and performs the following: Automatically detect views; Automatically detect anatomical structures within the supported views; Automatically verify quality criteria of the supported views by checking whether they conform to standardized quality criteria

Recalls

Date	Firm	Reason
2026-09-24	Philips Ultrasound, LLC	Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of
2026-08-07	Philips Ultrasound, LLC	Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measure
2025-10-31	Philips Ultrasound, LLC	Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
2025-10-09	B-K Medical A/S	GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif
2025-10-09	B-K Medical A/S	GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif
2025-10-09	B-K Medical A/S	GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif
2025-10-09	B-K Medical A/S	GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif
2025-10-09	B-K Medical A/S	GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif
2025-10-09	B-K Medical A/S	GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif
2025-09-18	GE Medical Systems, LLC	The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.