# FDA recall Z-0480-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2018-09-25.

## Product

Giraffe Incubator Carestation. Neonatal incubator.  Device sold under the following product names: Carestation and Carestation CS1

## Reason for recall

Potential electric leakage affecting the user.

## Distribution

Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-0480-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-25
- **Report date:** 2018-11-28
- **Termination date:** 2020-07-13

- **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-0480-2019

## Citation

> AI Analytics. FDA recall Z-0480-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0480-2019. Source: US FDA. Licensed CC0.

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