Avalon Ultrasound Transducers Recalled for Inaccurate Fetal Heart Rate Monitoring
Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product—fetal monitoring devices are critical to detecting abnormalities during pregnancy. Although no injuries have been reported, inaccurate measurements in multi-fetus monitoring pose a potential for delayed detection of fetal distress, justifying a High severity rating.
Plain-English summary
Philips North America LLC is recalling the Avalon ultrasound transducer, a medical device used to monitor fetal heart rate during pregnancy. The device directs a low-energy ultrasound beam toward the fetal heart and externally monitors the heart rate.
The recall addresses a potential for inaccurate fetal heart rate measurements when the device is used to monitor multiple fetuses (such as twins or triplets). Inaccurate measurements could potentially delay detection of fetal distress.
Approximately 6,915 units of the Avalon ultrasound transducer (Model No. 867246) have been distributed worldwide, including throughout the United States and internationally.
The recalled product
- Product
- Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 6,915
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 867246
- UDI: 00884838093195
- Serial No. DE67535433
- DE67535436
- DE67535443
- DE67535447
- DE67535452
- DE67535462
- DE67535463
- DE67535464
- DE67535470
- DE67535471
- DE67535474
- DE67535476
- DE67535479
- DE67535480
- DE67535483
- DE67535484
- DE67535487
- DE67535488
Distribution
Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
Same hazard · measurement inaccuracy
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- ModeratePhilips Tempus Pro Patient Monitor Software Update for Operational Issues
FDA (Devices) · 2025-05-14
- SevereVentilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure
FDA (Devices) · 2024-11-20
- SevereAeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols
FDA (Devices) · 2024-11-20
- SevereTrilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation
FDA (Devices) · 2024-11-20