FDA-Device2020-06-24Class II
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
GE Healthcare, LLC
Hazard
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.
Sold states
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 Kong, India, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Republic of Korea, Kuwait, Latam, Latvia, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, OMAN, State of Palestine, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen
Affected count
5,883 units total
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2236-2020Don't want to check this manually?
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