Company: GE Healthcare, LLC
Date of Enforcement Report: 1/22/2020
Class I

PRODUCT

CARESCAPE Respiratory Module E-sCO

• Recall Number: Z-0754-2020

CARESCAPE Respiratory Module E-sCOVX

• Recall Number: Z-0755-2020

CARESCAPE Respiratory Module E-sCAiO

• Recall Number: Z-0756-2020

CARESCAPE Respiratory Module E-sCAiOV

• Recall Number: Z-0757-2020

CARESCAPE Respiratory Module E-sCAiOE

• Recall Number: Z-0758-2020

CARESCAPE Respiratory Module E-sCAiOVE

• Recall Number: Z-0759-2020

Airway Gas Option N-CAiO

• Recall Number: Z-0760-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 9/27/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

167 units

DISTRIBUTION

International