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  5. Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury
  1. Medical Device Recalls

Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury

This recall involves updating instructions for using certain 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

Correct Assembly: Thread shank not visible, only shoulder can be seen.

Figure 1: Correct Assembly: Thread shank not visible, only shoulder can be seen.

Incorrect Assembly: Shoulder and thread shank both are visible.

Figure 2: Incorrect Assembly: Shoulder and thread shank both are visible.

  • Product Names: Giraffe OmniBed and Giraffe OmniBed CareStation 
    • Giraffe OmniBed: All models
  • Giraffe OmniBed CareStation: 00840682116862/All models
  • Lot/Serial Numbers: See full list of affected devices

What to Do

  • Do not move the canopy if a high priority alarm goes off and canopy movement stops.
  • Follow all user manual instructions for pre-use steps, which include checking the function of the heater doors before clinical use. 

Reason for Recall

GE HealthCare and subsidiary Datex-Ohmeda Inc. are updating use instructions for the Giraffe OmniBed and Giraffe OmniBed CareStation after reports that the screw securing the warmer heater doors may not be properly tightened, causing the heater doors to become loose. If doors become loose, a High Priority alarm goes off and canopy movement stops. If users attempt to force the canopy to keep moving, the doors may become damaged and could potentially fall on the patient.

The use of affected product may cause serious adverse health consequences from even minor trauma in the neonatal patient, including deep soft tissue injuries, traumatic brain injuries, and death.

There have been no reported injuries and no reports of death.

Device Use

Giraffe OmniBed and Giraffe OmniBed CareStations are combination infant incubator and infant warmer. The device can be operated as either an incubator or as a warmer and can transition from one mode to the other on demand. It cannot be operated in both modes at the same time. Incubators and warmers provide controlled warmth for newborns (neonates) who are unable to regulate their own body temperatures. Incubators provide an enclosed, temperature-controlled environment and warmers provide controlled heat in an open environment. These devices may also be used for short periods of time to help a neonate transition from the uterus to the external environment. 

Contact Information

Customers in the U.S. with questions about this recall should contact GE Healthcare Service at 1-800-437-1171 or a local service representative.

AnchorFull List of Affected Devices

Additional FDA Resources

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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