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Device Lab 48

Infant Incubator

Infant Incubator in the BMEssentia 3D Device Lab

The loop closes on an air temperature sensor sitting at the defined reference point above the centre of the mattress. The controller compares that reading with a setpoint and modulates a heating element until they agree, which they do within about half a minute. Nothing in this configuration measures the baby, nothing touches the baby, and the baby’s temperature is whatever the resulting environment gives it.

Also called: Neonatal Incubator. Arabic: حاضنة الأطفال. Device Lab 48 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Air control

The loop closes on an air temperature sensor sitting at the defined reference point above the centre of the mattress. The controller compares that reading with a setpoint and modulates a heating element until they agree, which they do within about half a minute. Nothing in this configuration measures the baby, nothing touches the baby, and the baby’s temperature is whatever the resulting environment gives it.

Skin-servo control

The same fan, the same element and the same hood, with the loop closed on a thermistor taped to the baby’s abdomen instead of on the air sensor. The controller drives the heater until the PROBE reads the setpoint, and the air temperature is no longer held at anything, it becomes the manipulated variable and goes wherever the baby’s losses require.

How it works: the main parts

What each part does, from the Infant Incubator lessons in the 3D Device Lab.

Mains inlet, isolation and alarm battery
An inlet, a fuse, a switch and an earth stud on the service face, and behind them two things worth separating: a transformer that isolates the patient from the supply, and a sealed battery whose only job is to keep the alarm alive after the supply has gone.
Stand, column and castors
A wheeled base, a single telescoping column with a clamp collar and a foot pedal, a drawer slung under the machine and an intravenous pole on one corner. It looks like furniture and three of its properties are engineering ones.
Double-walled hood
Two panes of clear acrylic three millimetres thick with a ten-millimetre air gap between them, bonded into moulded edges, lifting off in one piece. It is what makes this machine recognisable across a room, and its inner surface is the single most consequential temperature in the device.
Iris portholes and front access panel
Four circular ports with soft silicone cuffs and hinged clear doors, and a front wall that is entirely a drop-down access panel. Everything that is ever done to this patient is done through one of them, and each one is a hole in the boundary the machine is maintaining.
Cable and tube access grommets
Slotted rubber discs in both end walls, four of them, through which a ventilator circuit, three infusion lines, a probe lead and a set of monitoring leads all pass at once. They cost almost nothing and they are the largest continuous leak in the compartment.
Mattress tray, tilt and slide
A moulded tray with a raised lip, running on steel rails so that it slides out over the dropped front panel, with a lever at the head end that tilts it about twelve degrees either way and a cassette slot underneath.
Mattress
A foam slab in a welded wipe-clean cover, with a fitted sheet over it and a rolled nesting support along one side. It is the route everybody names first when asked how a baby loses heat in an incubator, and it is under one per cent of the answer.
Air intake filter
A pleated cartridge behind a grille low on the back of the base unit, with a latch and a date window. Everything this patient breathes for however many weeks they are in here came through it.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Detachment of Device or Device Component190
No Flow109
Break98
Overheating of Device26
Smoking25
Mechanical Problem21

Raw counts of adverse event reports for this device type (FDA product code FMZ, FPL), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.

Standards engineers test against

IEC 60601-2-19 and IEC 60601-2-21: infant incubators and radiant warmers

IEC 60601-2-19 covers infant incubators; IEC 60601-2-21 covers infant radiant warmers; IEC 60601-2-20 covers transport incubators.

Recent FDA recalls

RecallProduct and reason
Z-2475-2026
2026-06-17
GE Medical Systems, LLC: Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Root cause: Component design/selection.
Z-2476-2026
2026-06-17
GE Medical Systems, LLC: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Root cause: Component design/selection.
Z-2477-2026
2026-06-17
GE Medical Systems, LLC: Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Root cause: Component design/selection.
Z-0140-2025
2024-10-31
DATEX--OHMEDA, INC.: GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers:
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Root cause: Component design/selection.
Z-0141-2025
2024-10-31
DATEX--OHMEDA, INC.: GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers:
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Root cause: Component design/selection.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 44 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.

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