DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE — Class I medical device recall Z-2068-2014
Terminated recall by GE Healthcare, LLC, reported 2014-07-30, distributed nationwide. Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous de
| Recall number | Z-2068-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-06-11 |
| Classified | 2014-07-18 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2016-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BH, BR, CA, CH, CL, CN, CR, CZ, DE, DK, EG, ES, FI, FR, GB, GR, GT, HK, HR, ID, IL, IN, IQ, IT, JM, JP, KR, LB, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, RO, SA, SE, SG, SV, TH, TN, TR, TW, VE, ZA |
| Model numbers | 6818561, 6818574, 6822938, 6822939, 6822940, 6822942, 6822943, 6822944, 6822945, 6822946, 6822947, 6822948, 6822949, 6822951, 6822952, 6822953, 6822954, 6822955, 6822956, 6822957, 6822958, 6822959, 6822960, 6822962, 6822964 and 475 more |
Product
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
Reason for recall
Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 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-2068-2014. 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.