Philips Fetal Spiral Electrode-intended for patients requiring fetal… — Class II medical device recall Z-0908-2023
Ongoing recall by Philips North America Llc, reported 2023-01-18, distributed nationwide. Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention
| Recall number | Z-0908-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2022-11-21 |
| Classified | 2023-01-06 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, HR, IE, IL, IN, IQ, IS, IT, JO, JP, KW, LK, LU, LV, MY, NL, NO, NZ, OM, PT, QA, RU, SA, SE, SG, SI, SK, TT, ZA |
| UPC / GTIN / UDI-DI | 20884838007431 |
Product
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Reason for recall
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
Machine access
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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.