# FDA recall Z-1250-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-01-25.

## 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.

## Distribution

Distributed nationwide within US. Worldwide international distribution.

## Key facts

- **Recall number:** Z-1250-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-25
- **Report date:** 2019-05-08
- **Termination date:** 2020-12-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2019

## Citation

> AI Analytics. FDA recall Z-1250-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1250-2019. Source: US FDA. Licensed CC0.

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