Airway Gas Option N-CAiO — Class I medical device recall Z-0760-2020
Terminated recall by GE Healthcare, LLC, reported 2020-01-22. Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could c
| Recall number | Z-0760-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-09-27 |
| Classified | 2020-01-10 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2023-09-26 |
| Countries outside the US | AT, AU, BE, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, ES, FI, FR, HK, ID, IE, IN, IT, JP, KR, MX, MY, NL, NZ, PE, PL, RO, RS, RU, SE, TH, TR, TW, ZA |
| Quantity | 12 units |
| Serial numbers | SGV19248001HA, SGV19248004HA, SGV19258003HA, SGV19258005HA, SGV19258006HA, SGV19258009HA, SGV19258012HA, SGV19258020HA, SGV19268003HA, SGV19268004HA, SGV19268005HA, SGV19268009HA |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0760-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.