FDA Device recall Z-1250-2019
Fetal Spiral Electrode, Model No. 9898 031 37631
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of Fetal Spiral Electrode, Model No. 9898 031 37631 by Philips North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1250-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-25 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Fetal Spiral Electrode, Model No. 9898 031 37631
Reason
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.
Identifiers
| code_info | All products currently in distribution. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1250-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.