Recall Monitor
Health ProductsType I recall

Avalon US Transducer

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Avalon US Transducer
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalog number
Avalon US TransducerNot applicable.867246

Issue

The latest version of the wired Avalon ultrasound transducers (867246) may report inaccurate fetal heart rate (FHR) measurements when monitoring multiples (twins or triplets): in situations where the physiological signal (echo from the fetal heart) is absent or very weak (e.g. in early weeks of pregnancy), there is a tendency of the wired ultrasound transducers to interfere with each other and subsequently to produce an artificial FHR, mostly at approximately 180 bpm. The use cases affected by this issue are twin or triplet monitoring with wired ultrasound transducers including at least one transducer with software version l.01.04. The population at risk is women with multiple gestation (twins/triplets). Recall start date: March 10, 2025

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