# FDA recall Z-0047-2025

> **DATEX--OHMEDA, INC.** · Class I · device recall initiated 2024-09-03.

## Product

GE Heathcare Giraffe OmniBed; neo natal incubator

## Reason for recall

GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0047-2025
- **Recalling firm:** DATEX--OHMEDA, INC.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-03
- **Report date:** 2024-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wauwatosa, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0047-2025

## Citation

> AI Analytics. FDA recall Z-0047-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0047-2025. Source: US FDA. Licensed CC0.

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