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Fetal spiral electrode

Official notice

15 Dec 2022

MediumHealth Canada

An official Health Canada notice concerns Fetal spiral electrode. 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 Published 2022-12-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72326

Official notice

2022-12-15

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

72326

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Affected products

Product 1

Affected products - Fetal Spiral Electrode, Lot or serial number - Not applicable., Model or catalog number - 9898 031 37631

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Philips, Fetal Spiral Electrode.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

72326

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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