Recall Z-0760-2020— GE Healthcare, LLC

Name: FDA recall Z-0760-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-27

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2019-09-27, terminated 2023-09-26. It names one FDA 510(k) clearance: K133576. Product: Airway Gas Option N-CAiO. 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

510(k) clearances named in this recall

1 on FDA's record

K133576 — MONITOR B40Ge Medical Systems China Co., Ltd.·cleared 2014-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Airway Gas Option N-CAiO

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.