FDA Device recall Z-0908-2023
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor by Philips North America, citing 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 decid….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0908-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-21 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Reason
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.
Identifiers
| code_info | UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0908-2023%22
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