GE HealthCare Giraffe Omnibed Incubator Correction Issued Over Severe Infant Injury Risk

Heater doors on all GE HealthCare Giraffe Omnibeds and CareStations are capable of detaching and falling on infants.

Federal health officials are updating the instructions for Giraffe Omnibeds and Giraffe Omnibed CareStations, due to an improperly tightened screw on the products, which may allow the heater doors to detach and seriously injure newborn infants.

The Giraffe Omnibed and Giraffe Omnibed CareStation are intended for short-term use, providing controlled incubation or warming for premature or ill newborns. These products can function as either an incubator or a warmer, and they can switch between the two modes.

The U.S. Food and Drug Administration (FDA) announced the GE HealthCare Giraffe Omnibed and CareStation correction on October 31, warning healthcare providers to exercise extreme caution when using the products, due to the risk of the heater doors becoming loose and falling, which could cause severe and potentially life-threatening injuries.

GE HealthCare and its subsidiary, Datex-Ohmeda Inc., are updating the instructions for Giraffe Omnibed products following reports that the screws securing the warmers’ heater doors were improperly tightened, which could cause the doors to become loose and trigger an alarm.

This alarm stops the canopy from moving. An incubator canopy is a protective hood, which shields the baby and controls the baby’s environment within the incubator. If a caretaker attempts to force the canopy to move, the doors could detach and may fall on the infant, increasing the risk of deep soft tissue injuries, traumatic brain injuries or other potentially life-threatening injuries.

The FDA urges users not to move the canopy when the High Priority alarm sounds, and to follow all user manual instructions for pre-use steps, which include checking the functionality of the heater doors before clinical use.

This correction applies to all models of Giraffe Omnibeds and Giraffe Omnibed CareStations. A complete list of the affected models and their serial numbers can be found on the FDA’s correction notice.

While no injuries have been reported in connection with the products, the FDA has categorized this action as a Class I recall, which is the most serious type, indicating that continued use of the product could cause serious injury or death.

For questions regarding this recall, customers can contact GE Healthcare Service at 1-800-437-1171 or a local service representative.

Individuals can also report adverse reactions or quality problems to the FDA Safety Information and Adverse Event Reporting Program, MedWatch.