Giraffe OmniBed Carestation CS1Recalls & reported problems

Datex-Ohmeda, Inc. · GIRAFFE OMNIBED CARESTATION CS1 · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Datex-Ohmeda Giraffe OmniBed incubator has 231 adverse event reports, with no injuries and no deaths. The reports mostly describe parts coming loose or breaking, such as the heater door, and almost all report no patient effects. Both recalls are closed and started in June 2023, covering airborne formaldehyde from newly made incubators, which customers were told to run for a week to clear. Reports fell from 151 in the previous 12 months to 73 in the last 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 217
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 217 adverse event reports that list this exact device (DI 00840682116862), received between Nov 8, 2021 and Sep 29, 2026 — classified as 217 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (127 reports).

2 FDA recall records name this device's identifier.

14 other recalls cover devices cleared under the same FDA submission (K101788, K152814, K213551, K251663); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Jun 6, 2023Class ICompleted
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. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
Z-0141-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Jun 6, 2023Class ICompleted
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. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
Z-0140-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Device problems

Detachment of Device or Device Component127
Break40
No Flow21
Insufficient Flow or Under Infusion11
Difficult to Open or Close3
Infusion or Flow Problem3
Mechanical Problem3
Fire2

Patient problems

No Clinical Signs, Symptoms or Conditions216
Fall1

Recent adverse event reports

The 25 most recent of 217 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 29, 2026No Flow
It was reported that there was a malfunction during service resulting in loss of oxygen therapy.There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931593 ↗
MalfunctionSep 28, 2026Break
It was reported that the heater door was broken. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916609 ↗
MalfunctionSep 8, 2026Break
It was reported that the heater door was broken. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669265 ↗
MalfunctionSep 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50586824 ↗
MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142720 ↗
MalfunctionMay 20, 2026Detachment of Device or Device Component
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (RECALL NO. Z-0047-2025 & Z-0048-2025), THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE DESCRIBED IN THE RECALL NO. Z-0047-2025 & Z-0048-2025. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231718 ↗
MalfunctionMay 19, 2026Gas/Air Leak
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING RESULTING IN A HOSE CONNECTOR CAUSING LOSS OF AUXILIARY OXYGEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25223048 ↗
MalfunctionMay 15, 2026Detachment of Device or Device Component
THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE BEING ADDRESSED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (Z-0047-2025 & Z-0048-2025). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191951 ↗
MalfunctionMay 8, 2026Detachment of Device or Device Component
THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE BEING ADDRESSED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (Z-0047-2025 & Z-0048-2025). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124440 ↗
MalfunctionMay 5, 2026Detachment of Device or Device Component
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (RECALL NO. Z-0047-2025 & Z-0048-2025), THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE DESCRIBED IN THE RECALL NO. Z-0047-2025 & Z-0048-2025. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081278 ↗
MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25043100 ↗
MalfunctionApr 29, 2026Break
IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031826 ↗
MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING SERVICE RESULTING IN A BROKEN HEATER DOOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953126 ↗
MalfunctionApr 21, 2026No Flow
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF AUXILIARY OXYGEN DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939927 ↗
MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781447 ↗
MalfunctionMar 30, 2026Detachment of Device or Device Component
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (RECALL NO. Z-0047-2025 & Z-0048-2025), THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE DESCRIBED IN THE RECALL NO. Z-0047-2025 & Z-0048-2025. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717583 ↗
MalfunctionMar 30, 2026No Flow
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OXYGEN FAILURE DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713713 ↗
MalfunctionMar 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN THE HEATER DOOR SHOULDER SCREW DISENGAGING DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674570 ↗
MalfunctionMar 23, 2026Detachment of Device or Device Component
THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE BEING ADDRESSED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (Z-0047-2025 & Z-0048-2025). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661568 ↗
MalfunctionMar 17, 2026No Flow
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OXYGEN FAILURE DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615942 ↗
MalfunctionMar 17, 2026Detachment of Device or Device Component
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (RECALL NO. Z-0047-2025 & Z-0048-2025), THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE DESCRIBED IN THE RECALL NO. Z-0047-2025 & Z-0048-2025. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615549 ↗
MalfunctionMar 12, 2026No Flow
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580611 ↗
MalfunctionMar 9, 2026No Flow
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF AUXILIARY OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544094 ↗
MalfunctionMar 6, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24533113 ↗
MalfunctionMar 3, 2026Difficult to Open or Close
IT WAS REPORTED THAT THE HEATER DOOR WOULD NOT CLOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501152 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101788, K152814, K213551, K251663. One submission often covers many models, so check the product and lot details in each record.

Z-2477-2026 · May 1, 2026 · Open, Classified
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Z-2476-2026 · May 1, 2026 · Open, Classified
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
Z-2475-2026 · May 1, 2026 · Open, Classified
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Z-0047-2025 · Sep 3, 2024 · Open, Classified
GE Heathcare Giraffe OmniBed; neo natal incubator
Z-0048-2025 · Sep 3, 2024 · Open, Classified
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Z-2101-2023 · May 19, 2023 · Open, Classified
Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-003
Z-2100-2023 · May 19, 2023 · Open, Classified
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051,
Z-2235-2020 · Apr 28, 2020 · Terminated
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Z-2111-2020 · Apr 2, 2020 · Terminated
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Z-0539-2020 · Oct 11, 2019 · Terminated
Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
Z-0538-2020 · Oct 11, 2019 · Terminated
Giraffe OmniBed infant warmer
Z-0281-2020 · Jul 26, 2019 · Open, Classified
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot
Z-0479-2019 · Sep 25, 2018 · Terminated
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Z-1051-2013 · Jan 8, 2013 · Terminated
Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Heal

Device details

UDI-DI	`00840682116862`
Brand	Giraffe OmniBed Carestation
Model	CS1
Company	Datex-Ohmeda, Inc.
Product code	FMZ · INCUBATOR, NEONATAL
Class	Class 2
FDA submission	K101788, K152814, K213551, K251663
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 8, 2025

Device type (GMDN): Conventional infant incubator

A mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward.

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All INCUBATOR, NEONATAL devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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