Recall Z-0758-2020— GE Healthcare, LLC
Class I · Terminated
Class I FDA medical device recall by GE Healthcare, LLC, initiated 2019-09-27, terminated 2023-09-26. FDA's recall record names no specific 510(k) clearance for this event. Product: CARESCAPE Respiratory Module E-sCAiOE. 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
- GE Healthcare, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-09-27
- Terminated
- 2023-09-26
- Firm location
- Waukesha, WI, United States
Product description
CARESCAPE Respiratory Module E-sCAiOE
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.