FETOLY-HEART
DIAGNOLY · Model 1 · UDI-DI 03770033463000
1
510(k) clearances
2,691
Adverse events (35 deaths)
298
Recalls
221
Facilities
Description
Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 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 |
| 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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Get your free API keyRead the docsData 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.