[Recalled] Airway Gas Option N-CAiO — Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values… | FDA 2019-09-27
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Airway Gas Option N-CAiO |
|---|---|
| Brand / manufacturer | GE Healthcare, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0760-2020 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 27 September 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from GE Healthcare, LLC
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.