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Health Canada Health products

Avalon Fetal Monitor - Risk of Inaccurate Ultrasound-Derived Fetal Heart Rate Monitoring

Issued October 9, 2019
Issue
Reports of inaccurate FHR monitoring, including outcomes of stillbirth and low Apgar score, have been reported with the use of the Avalon Fetal Monitor in Canada and internationally. Although Health Canada’s review of the available information found that inaccurate FHR monitoring has been observed in some cases, there was insufficient evidence to establish a link between the use of the Avalon Fetal Monitor and adverse fetal outcome. A review of the literature shows that all continuous FHR monitors that use Doppler ultrasound to derive FHR have the potential to show inaccurate readings.
Hazard description
Product safety