Revised Guidelines for Neonatal Incubators: GE HealthCare Modifies Usage Instructions for Giraffe OmniBed and Incubator Carestation Addressing Patient Formaldehyde Exposure Risks

This recall is focused on revising the usage instructions for the devices and does not require their removal from operation or sale. This recall is classified by the FDA as the most significant type due to the risk of serious injuries or fatalities if updated guidelines are not followed.

Details of the 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

Action Steps

No significant issues are anticipated with the affected devices, but the following instructions are provided for clarity:

• New GE HealthCare Giraffe OmniBed Carestations or Giraffe Incubator Carestations:
  • Devices received after September 5, 2023 do not require a one-week operational period prior to clinical use.
    • For devices received before September 5, 2023 that are not yet in clinical use, please assemble and run the incubator in a well-ventilated area with maximum heat and humidity, keeping air openings and bedside panels shut, for one week prior to clinical use.
  • Contact your local GE HealthCare representative for any inquiries about your new neonatal incubator.
• If your incubator is currently in use, continue its operation. These incubators are vital for neonates (infants under four weeks old) unable to regulate their body temperature.

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

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

On June 6, 2023, GE HealthCare shared the following guidance, included here for reference:

• Run all new GE HealthCare OmniBed Carestation or Incubator Carestations for a week in a well-ventilated area post-assembly and before clinical deployment.
  • Utilize peak incubator heat and humidity settings.
  • Ensure all ports and bedside panels are closed.
• Continue operating incubators that are currently in clinical use, as they are essential for neonates facing temperature regulation challenges.

Rationale for Instruction Updates

GE HealthCare, along with its subsidiary Datex-Ohmeda, Inc., revised the usage instructions for Giraffe Omnibed Carestation and Incubator Carestation based on initial tests indicating potentially elevated formaldehyde levels for neonates during the initial week of use. These levels diminish significantly after this period. GE HealthCare has since initiated a process on September 5, 2023, aimed at lowering formaldehyde levels in newly manufactured neonatal incubators before their release.

Utilization of the affected products could lead to severe health implications, such as neurological or respiratory issues, along with risks of nasal, mouth, or throat cancer.

Currently, no injuries or fatalities have been reported. GE HealthCare has not documented any incidents of patient harm or adverse reactions linked to potential formaldehyde exposure arising from the incubators. At this time, no indications suggest that observed formaldehyde levels in GE HealthCare incubators have resulted in negative health outcomes.

Device Purpose

The Giraffe Omnibed Carestation and Incubator Carestation serve as neonatal incubators. These devices are crucial for the care of newborns within hospital environments, particularly in neonatal intensive care units (NICU). They provide a controlled and supportive environment crucial for infants who require assistance with maintaining their body temperature.

Customer Support

U.S. customers with questions regarding this recall are encouraged to reach out to GE HealthCare at 1-800-437-1171 or connect with their local GE HealthCare representative.

Further FDA References (arranged by recency):

• FDA Letter to Health Care Providers [11/08/2024]: Evaluation of Airborne Chemicals from Neonatal Incubators
• FDA’s Enforcement Report
• Medical Device Recall Database

Unique Device Identifier (UDI) Explanation

The unique device identifier (UDI) is critical for distinguishing individual medical devices distributed within the United States, from production through distribution to patient application. The UDI system facilitates improved accuracy in reporting, reviewing, and analyzing adverse event data, ultimately enabling the prompt identification and resolution of potential device-related issues.

How to Report Issues

Healthcare professionals and consumers are encouraged to report any adverse reactions or quality issues encountered while using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.