GE Healthcare, LLC recalls Giraffe Incubator with installed Servo Oxygen module. Infant incubator.

Recall date

April 28, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2236-2020

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution. US nationwide including US Virgin Islands, Australia, Austria, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Hong Kon…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Giraffe Incubator with installed Servo Oxygen module. Infant incubator.