GE Healthcare recalls Airway Gas Option N-CAiO devices with potential up to 50% error in oxygen measurements, which could lead to unsafe oxygen levels during medical use.
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.
GE Healthcare is recalling Airway Gas Option N-CAiO devices because they may show incorrect oxygen levels, risking unsafe patient care. This error could cause up to 50% measurement inaccuracies in critical oxygen readings.
The device may display incorrect End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values, leading to up to 50% measurement errors. This could result in patients receiving too little or too much oxygen, potentially causing harm during medical treatment.
Healthcare providers using the Airway Gas Option N-CAiO devices for patient oxygen monitoring are likely affected. Patients receiving oxygen therapy through these devices could be at risk if the measurements are inaccurate.
Check for the model name 'Airway Gas Option N-CAiO' and the specific manufacturing lot or serial numbers listed in the recall notice. The devices were sold with the serial numbers starting with SGV19248001HA through SGV19268009HA.
Verify the device model is 'Airway Gas Option N-CAiO' and check for the listed serial numbers in the recall notice.
The Airway Gas Option N-CAiO devices may display incorrect End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values, which could lead to up to 50% measurement errors.
Check the device model and serial numbers against the list provided in the recall notice. If it matches, contact GE Healthcare for further instructions.
The recall states the error could lead to up to 50% measurement inaccuracies, but the specific risk of serious injury is not detailed in the notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0760-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0760-2020 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
