medical Class II Updated 2020-06-24

GE Healthcare, LLC recalls Giraffe OmniBed with installed Servo Oxygen module. Infant i

Recalled Product

Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.

Hazard / Issue

Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Giraffe Incubator: serial numbers HDHA through HDHQ; Servo Oxygen Board spare part kit: 6600-0233-850; Servo Oxygen upgrade kits: 6600-0678-800, 6600-0678-801, 6600-0678-802, 6600-0678-803, 66000849-800, 6600-0849-801, 6600-0849-802, 6600-0849-803, 6600-0866-800, 6600-0866-801, 6600-0867800, 6600-0867-801, M1142293 or M1142295.
View official government recall

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