# FDA recall Z-0281-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-07-26.

## Product

Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

## Reason for recall

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

## Distribution

Worldwide distributions - US Nationwide in the states of CA, CT, FL, ID, IL, KS, MI, NC, NC, NJ, NM, PA, TX, VA.      Countries of China, France, Germany, Korea, Republic of China.

## Key facts

- **Recall number:** Z-0281-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-26
- **Report date:** 2019-11-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2020

## Citation

> AI Analytics. FDA recall Z-0281-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0281-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*