# FDA recall Z-2235-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-04-28.

## Product

Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.

## Reason for recall

Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.

## Distribution

Worldwide Distribution.  US nationwide including US Virgin Islands,   Australia,   Austria,   Bahrain,   Belgium,   Bermuda,   Bulgaria,   Burundi,   Canada,   Chile,   China,   Croatia,   Czech Republic,   Denmark,   Dominican Republic,   Ecuador,   Egypt,   El Salvador,   Estonia,   Finland,   France,   Germany,   Greece,   Guernsey,   Hong Kong,   India,   Ireland,   Israel,   Italy,   Japan,   Jersey,   Jordan,   Kazakhstan,   Republic of Korea,   Kuwait,   Latam,   Latvia,   Lithuania,   Macedonia,   Malaysia,   Mexico,   Morocco,   Netherlands,   New Zealand,   Norway,   OMAN,   State of Palestine,    Panama,   Peru,   Poland,   Portugal,   Qatar,   Romania,   Russia,   Saudi Arabia,   Singapore,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Tunisia,   Turkey,   Ukraine,   United Arab Emirates,   United Kingdom,   Uruguay,   Venezuela,   and Yemen

## Key facts

- **Recall number:** Z-2235-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-28
- **Report date:** 2020-06-24
- **Termination date:** 2024-09-23

- **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-2235-2020

## Citation

> AI Analytics. FDA recall Z-2235-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2235-2020. Source: US FDA. Licensed CC0.

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