FDA-Device2019-05-08Class II
Fetal Spiral Electrode, Model No. 9898 031 37631
Philips North America, LLC
Hazard
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.
Sold states
Distributed nationwide within US. Worldwide international distribution.
Affected count
1,971,925 (78,877 boxes)
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Fetal Spiral Electrode, Model No. 9898 031 37631
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2019Don't want to check this manually?
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