GE Healthcare, LLC recalls CARESCAPE Respiratory Module E-sCAiOE

Hazard / Issue

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.

Issued by

FDA

Distribution: 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

Lot/Code Info: Mfg. Lot or Serial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ot Applicable SGV16434022HA Not Applicable SGV19269615HA Not Applicable