Model note · Infant Incubator
GE Giraffe Incubator and Giraffe Incubator Carestation CS1
The Giraffe Incubator is GE's closed neonatal incubator, first cleared in 2001. The Carestation CS1 is its current version, alongside the Giraffe OmniBed, which can also open as a radiant warmer. It controls temperature by baby skin or by air, with servo humidity and an optional Servo Oxygen Module. In 2021 the porthole latches were redesigned to rotate to open, with a secondary catch. Its recalls are worth knowing for any neonatal unit: panels and portholes that look closed but are not latched (fall risk), oxygen that differs from the display on pre 2012 units, leakage current through the USB and nurse call ports, and formaldehyde from new units in their first week.
The model
Maker, model and type.
- Maker
- Datex-Ohmeda, Inc. (formerly Ohmeda Medical; GE HealthCare)
- Model
- Giraffe Incubator and Giraffe Incubator Carestation CS1
- Device type
- Infant Incubator
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification and clearances | Neonatal incubator, product code FMZ; Giraffe Incubator from K010222 (2001); Incubator Carestation CS1 K152809 (2015), K213553 (2 March 2022, porthole latch redesign), K251663 (2025), K260326 (28 July 2026) | Source |
| Control settings (CS1 family) | Baby (patient) control 35 to 37.5 degrees C and air control 20 to 39 degrees C, both in 0.1 degree steps; servo humidity 30 to 95% relative humidity in 5% steps | Source |
| Operating environment | 20 to 30 degrees C room, 10 to 95% humidity non condensing, room air velocity up to 0.3 m/s | Source |
| Latches (2021 design) | Portholes rotate clockwise or anticlockwise to open; north side wall latches have a primary and a secondary latching point; side panels open by pinching | Source |
| Options | Servo Oxygen Module; USB and RS232 nurse call ports; uninterruptible power supply option (2007 clearance) | Source |
Recalls
Known FDA recalls.
- Z-0141-20252023-06-06
Higher airborne formaldehyde from newly made incubators in their first week (224 units).
FDA record - Z-2236-20202020-04-28
Pre 2012 units with the Servo Oxygen Module may deliver oxygen different from the display (5,883 units).
FDA record - Z-0540-20202019-10-11
Bedside panels and portholes can look closed without being latched; fall risk (3,467 units).
FDA record - Z-0480-20192018-09-25
Possible electric leakage affecting the user (1,724 devices).
FDA record - Z-1502-20172016-11-18
Certain power cords could overheat.
FDA record - Z-1051-20132013-01-08
Display boards may overwrite stored settings and set points at power up or after a power failure.
FDA record
Safety
Safety warnings from the record.
- An unlatched panel or porthole can let the baby fall. Source
- Until tested, GE advised disconnecting devices from the USB and RS232 nurse call ports because of possible leakage current to the user. Source
- Newly made units could release formaldehyde that falls quickly over about a week (224 units, 2023). Source
Sources
Where this note comes from.
- FDA 510(k) K213553 summary, Giraffe Incubator Carestation CS1 (latch redesign)
- openFDA 510(k) records for Giraffe Incubator
- openFDA device recall records for Giraffe Incubator
Not covered: The comparison table in K213553 is shared with the Giraffe OmniBed Carestation, so some settings may be family values rather than incubator only; the radiant heat line was left out for that reason. The service manual and IFU were not read, so alarm messages, weigh scale accuracy, battery time and maintenance intervals are not included. The skin probe point in the design note is general incubator practice, not a GE statement.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Infant Incubator