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  5. Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure
  1. Medical Device Recalls

Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure

The devices described in this recall are the same devices announced in the related Letter to Health Care Providers. On November 8, 2024 the FDA issued an update to the Letter to Health Care Providers to provide the most recent recommendations provided by GE HealthCare.

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

  • Product Names: Giraffe OmniBed Carestation CS1; Giraffe Incubator Carestation CS1
  • Unique Device Identifier (UDI)/Model/Product Codes:
    • UDI: 00840682116862 for Giraffe OmniBed Carestation CS1 and
    • UDI: 00840682116855 for Giraffe Incubator Carestation CS1

What to Do

Please note, all affected devices are believed to be corrected. The FDA is providing the following instructions, here for completeness:

  • New GE HealthCare Giraffe OmniBed Carestations or Giraffe Incubator Carestations:
    • Received after September 5, 2023, do not need to run for a week before clinical use.
      • Received before September 5, 2023, that have not been put into clinical use, please assemble the new incubator with all components and run it for a week in a well-ventilated space with maximum heat and humidity, and portholes and bedside panels closed, prior to clinical use.
    • Contact your local GE HealthCare representative if you have any questions about your new neonatal incubator.
  • If your incubator is in clinical use, continue to use it. Incubators are critical for neonates (infants less than four weeks old) that cannot maintain their body temperature.

Unique Device Identifier (UDI) information provided by GE HealthCare:

  • Giraffe OmniBed Carestation: 00840682116862
  • Giraffe Incubator Carestation: 00840682116855

GE HealthCare provided the following instructions to customers on June 6, 2023, which are provided here for completeness:

  • Run all new GE HealthCare OmniBed Carestation or Incubator Carestations for a week in a well-ventilated space after assembly and before clinical use.
    • Use maximum incubator heat and humidity.
    • Close all portholes and bedside panels.
  • Continue to use incubators that are already in clinical use, as they are critical for neonates (infants less than four weeks old) who cannot maintain body temperature.

Reason for Updates to Use Instructions

GE HealthCare and its subsidiary Datex-Ohmeda, Inc., previously updated use instructions for Giraffe Omnibed Carestation and Incubator Carestation due to preliminary testing of newly manufactured incubators that suggested potentially higher levels of formaldehyde exposure for neonates in the first week of device use. These levels rapidly decrease after the first week. GE HealthCare later implemented a process on September 5, 2023, to reduce the levels of formaldehyde from new neonatal incubators before distribution.

The use of affected product may cause serious adverse health consequences, including neurological impairment or respiratory problems (such as asthma, decreased lung function, inflammation, or irritation) and nasal, mouth or throat cancer.

There have been no reports of injuries and no reports of death. GE HealthCare has not received any reports of patient injury or adverse effects related to potential exposure to formaldehyde in incubators. At the present time there is not evidence that the levels of formaldehyde observed in GE HealthCare incubators have led to adverse health effects.

Device Use

Giraffe Omnibed Carestation and Incubator Carestation are neonatal incubators. These devices are critical to care for newborns in hospital settings such as neonatal intensive care units (NICU). The incubators help create an optimal environment for newborns that need support in regulating their body temperature, by providing heated and humidified air within an enclosed bed compartment.

Contact Information

Customers in the U.S. with questions about this recall should contact GE HealthCare at 1-800-437-1171 or their local GE HealthCare representative.

Additional FDA Resources (listed in order of most to least recent):

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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