Product Wiki · Recalls · Health Canada — Medical Devices

Fetal Spiral Electrode — recall 72326

Health Canada — Medical Devices · Canada · 2022-12-15 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
72326
Date of alert
2022-12-15
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Obstetrics and gynaecology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/fetal-spiral-electrode-0

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