FETOLY
DIAGNOLY · Model 1 · UDI-DI 03770033463024
Description
FETOLY 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 fetal brain and heart in real-time. FETOLY can be used by HCPs during fetal ultrasound examination 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 fetal brain and heart ultrasound examination in accordance with national and international guidelines. FETOLY is also intended to be used to realize biometric measurements of the fetal brain and heart in accordance with national and international guidelines.
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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