# FDA recall Z-0908-2023

> **Philips North America Llc** · Class II · device recall initiated 2022-11-21.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain,  Belgium, Canada, China, Croatia, Cura¿ao, Czechia, Denmark, Faroe Islands, Finland,  France, Germany, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan,  Kuwait, Latvia, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Oman, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia,  South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tanzania, United Republic  Trinidad and Tabago, United Arab Emerates, United Kingdom.

## Key facts

- **Recall number:** Z-0908-2023
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-21
- **Report date:** 2023-01-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0908-2023

## Citation

> AI Analytics. FDA recall Z-0908-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0908-2023. Source: US FDA. Licensed CC0.

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