Health product recall

Fetal Spiral Electrode

Last updated

Summary

Product
Fetal Spiral Electrode
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
Fetal Spiral Electrode Not applicable. 9898 031 37631

Issue

Philips has found that the spiral tip of the Fetal Sprial Electrode (FSE) may break off during use, potentially requiring surgical intervention to remove the broken tip from the patient. Based on Philips investigation, this can occur due to over rotation during attachment or pulling the tip from the fetal scalp. The FSE may also break off if the user pulls the spiral tip from the fetal skin, increasing the risk of the spiral tip detaching from the FSE during removal.

Recall start date: November 24, 2022

Additional information

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

Philips Medical Systems

3000 Minuteman Road, Andover, Massachusetts, United States, 01810

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72326

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