Fetal Spiral Electrode, Model No. 9898 031 37631
Reported: May 8, 2019 Initiated: January 25, 2019 #Z-1250-2019
Product Description
Fetal Spiral Electrode, Model No. 9898 031 37631
Reason for Recall
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.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 1,971,925 (78,877 boxes)
- Distribution
- Distributed nationwide within US. Worldwide international distribution.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Fetal Spiral Electrode, Model No. 9898 031 37631. Recalled by Philips North America, LLC. Units affected: 1,971,925 (78,877 boxes).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2019. Severity: Moderate. Recall number: Z-1250-2019.
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