Health product recall

Avalon US Transducer

Last updated

Summary

Product
Avalon US Transducer
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Avalon US Transducer

Not 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Philips Medizin Systeme Boblingen GmbH

Hewlett-Packard Strasse 2, Boblingen, Germany, 71034

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-77107

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