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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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