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

Starting date:

January 29, 2019

Posting date:

March 1, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69180

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  Reason
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  Affected products

Affected Products

Fetal Scalp Electrode, Single Spiral

Reason

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.

Affected products