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Philips North America, LLC recalls Fetal Spiral Electrode, Model No. 9898 031 37631
Recalled May 8, 2019 · FDA recall Z-1250-2019 · Philips North America
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. · FDA Class II
Units
1,971,925 (78,877 boxes)
Sold at
Distributed nationwide within US. Worldwide international distribution.
Description
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.
Product
Fetal Spiral Electrode, Model No. 9898 031 37631
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →