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