FDA-Device2020-01-22Class I
CARESCAPE Respiratory Module E-sCAiOV
GE Healthcare, LLC
Hazard
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Sold states
US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom
Affected count
37 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
CARESCAPE Respiratory Module E-sCAiOV
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0757-2020Don't want to check this manually?
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