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Health Canada Medical devices

Fetal Spiral Electrode

Issued December 15, 2022
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
Hazard description
Performance
Product
Product name
Fetal Spiral Electrode
Reference
ID
RA-72326