GE Healthcare, LLC recalls CARESCAPE Respiratory Module E-sCAiOE

Recall date

September 27, 2019

Source

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

Recall number

Z-0758-2020

FDA classification

Class I

Brand / firm

GE Healthcare, LLC

Sold / distributed

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,…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CARESCAPE Respiratory Module E-sCAiOE