FDA Devices Critical Class I Terminated

CARESCAPE Respiratory Module E-sCAiO

Reported: January 22, 2020 Initiated: September 27, 2019 #Z-0756-2020

Product Description

Reason for Recall

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.

Details

Recalling Firm: GE Healthcare, LLC
Units Affected: 161 units
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
Location: Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼

CARESCAPE Respiratory Module E-sCAiO. Recalled by GE Healthcare, LLC. Units affected: 161 units.

Why was this product 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.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 22, 2020. Severity: Critical. Recall number: Z-0756-2020.