FDA (Devices) recall action 84034
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE Healthcare is recalling 12 units of the Airway Gas Option N-CAiO because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling 161 CARESCAPE Respiratory Module E-sCAiO units because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling 37 CARESCAPE Respiratory Modules because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling three CARESCAPE Respiratory Module E-sCOVX units because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling 59 CARESCAPE Respiratory Modules because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling 167 CARESCAPE Respiratory Module E-sCO units because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling 14 CARESCAPE Respiratory Module E-sCAiOVE units because displayed oxygen values may be incorrect, causing up to 50% measurement error.