FDA Device recall Z-2235-2020
Giraffe OmniBed with installed Servo Oxygen module
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Giraffe OmniBed with installed Servo Oxygen module by Ge Healthcare, citing 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 compone….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2235-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-28 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Reason
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.
Identifiers
| code_info | Giraffe Incubator: serial numbers HDHA through HDHQ; Servo Oxygen Board spare part kit: 6600-0233-850; Servo…Giraffe Incubator: serial numbers HDHA through HDHQ; Servo Oxygen Board spare part kit: 6600-0233-850; Servo Oxygen upgrade kits: 6600-0678-800, 6600-0678-801, 6600-0678-802, 6600-0678-803, 66000849-800, 6600-0849-801, 6600-0849-802, 6600-0849-803, 6600-0866-800, 6600-0866-801, 6600-0867800, 6600-0867-801, M1142293 or M1142295. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2235-2020%22
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