Fetal Spiral Electrode — Class II medical device recall Z-1250-2019
Terminated recall by Philips North America, LLC, reported 2019-05-08, distributed nationwide. During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp
| Recall number | Z-1250-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2019-01-25 |
| Classified | 2019-05-02 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2020-12-08 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Model numbers | 031, 37631, 9898 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1250-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.