Philips North America, LLC recalls Fetal Spiral Electrode, Model No. 9898 031 37631

Recall date

January 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1250-2019

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

Distributed nationwide within US. Worldwide international distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fetal Spiral Electrode, Model No. 9898 031 37631