FDA-Device2019-11-13Class II
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.
GE Healthcare, LLC
Hazard
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Sold states
Worldwide distributions - US Nationwide in the states of CA, CT, FL, ID, IL, KS, MI, NC, NC, NJ, NM, PA, TX, VA. Countries of China, France, Germany, Korea, Republic of China.
Affected count
59 devices (50 US, 9 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2020Don't want to check this manually?
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