Product Wiki · Recalls · Health Canada — Medical Devices

Fetal Scalp Electrode, Single Spiral (2019-01-29) — recall 59064

Health Canada — Medical Devices · Canada · 2019-03-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59064
Date of alert
2019-03-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: During use of the Philips FSE it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery. Beginning in 2018, Philips has noted an increase in the number of reports of tip breakage received from customers.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/fetal-scalp-electrode-single-s

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