Health product recall

Sonicaid Freedom Wireless Fetal Monitoring System

Last updated

Summary

Product
Sonicaid Freedom Wireless Fetal Monitoring System
Issue
Medical devices - Performance issue
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
Sonicaid Freedom Wireless Fetal Monitoring System 778EW10002421 778EW10002621 778EW10002521 SF1-SL

Issue

Huntleigh has received a report from a user regarding the potential for inappropriate clinical diagnosis and action due to the incorrect setup of the RF channels. In the particular case in question, both units had been inadvertently set to the same RF channel and were placed in close proximity to each other, leading to the second unit displaying the FHR from the first unit.

Recall start date: October 19, 2022

Additional information

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

Huntleigh Healthcare Ltd.

35 Portmanmoor Road, Cardiff, Great Britain, CF24 5HN

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72082

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