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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
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 U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
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.
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