CLASS I Device recall · Reported 22 Jan 2020 · FDA Enforcement Report

Airway Gas Option N-CAiO recalled by GE Healthcare

GE Healthcare is recalling Airway Gas Option N-CAiO. The recall was initiated on 27 Sep 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesMfg. Lot or Serial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

Quantity recalled12 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0760-2020
FDA event ID: 84034
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class I
Status: Terminated
Recall initiated: 27 Sep 2019
FDA classified: 10 Jan 2020
Reported: 22 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Sep 2019	Recall initiated by company
10 Jan 2020	Classified by FDA	+105 days
22 Jan 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Airway Gas Option N-CAiO

Where it was distributed

US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Mfg. Lot or Serial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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 84034

This product is part of a recall event; the main page for the event is Carescape Respiratory Module E-sCAiOV recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
22 Jan 2020	CLASS I	Carescape Respiratory Module E-sCAiOV recalled by GE Healthcare	GE Healthcare	Other	WI
22 Jan 2020	CLASS I	Carescape Respiratory Module E-sCAiO recalled by GE Healthcare	GE Healthcare	Other	WI
22 Jan 2020	CLASS I	Carescape Respiratory Module E-sCAiOVE recalled by GE Healthcare	GE Healthcare	Other	WI
22 Jan 2020	CLASS I	Carescape Respiratory Module E-sCAiOE recalled by GE Healthcare	GE Healthcare	Other	WI
22 Jan 2020	CLASS I	Carescape Respiratory Module E-sCO recalled by GE Healthcare	GE Healthcare	Other	WI
22 Jan 2020	CLASS I	Carescape Respiratory Module E-sCOVX recalled by GE Healthcare	GE Healthcare	Other	WI

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