CARESCAPE Respiratory Modules E-sCO — Class II medical device recall Z-2617-2014
Terminated recall by GE Healthcare, LLC, reported 2014-09-17, distributed in CA, CO, FL, GA, IN, KY, LA, MD…. GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component
| Recall number | Z-2617-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-08-08 |
| Classified | 2014-09-09 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2015-09-08 |
| Distributed | CA, CO, FL, GA, IN, KY, LA, MD, MI, NC, NY, OH, PA, SC, TN, TX, VA, WI |
| Countries outside the US | AU, BE, BG, CH, CL, CO, CZ, DE, EG, ES, FI, FR, GB, ID, IN, IT, JP, KR, KW, LB, MX, NI, NL, NO, NZ, PA, PH, PK, SA, SE, SG, TH, TR, ZA |
Product
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor
Reason for recall
GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.
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-2617-2014. 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.