GE Healthcare — Class II medical device recall Z-1808-2014
Terminated recall by GE Healthcare, LLC, reported 2014-06-25, distributed nationwide. Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump
| Recall number | Z-1808-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-05-23 |
| Classified | 2014-06-17 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2015-10-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HU, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LB, LT, MA, MX, NL, NO, NZ, PA, PE, PL, PT, QA, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, VE, VN, ZA |
| Serial numbers | 6704120, 6704121, 6704122, 6704124, 6704126, 6704127, 6704128, 6704129, 6704130, 6704132, 6704133, 6704134, 6704135, 6704137, 6704138, 6704141, 6704142, 6704143, 6704144, 6704146, 6704147, 6704148, 6704149, 6704150, 6704151 and 475 more |
Product
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
Reason for recall
Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. If this issue occurs, the monitor will show an alarm note on monitor screen of either "Low gas sample flow" or "Check sample gas out".
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-1808-2014. 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.