FDA Device recall Z-2617-2014
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE
- FDA Device
- Class II
- terminated
- Published 2014-09-17
On 2014-09-17 the FDA classified a Class II recall of CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE by Ge Healthcare, citing 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 Op….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2617-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-08 |
| Published | 2014-09-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | CA, CO, FL, GA, IN, KY, LA, MD, MI, NC, NY, OH, PA, SC, TN, TX, VA, WI |
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
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.
Identifiers
| code_info | Mfg Lot or Serial # System ID SGV14019647HA M1199109 SGV14127799HA M1199109 SGV14138150HA M1198397 SGV14148747HA M1…Mfg Lot or Serial # System ID SGV14019647HA M1199109 SGV14127799HA M1199109 SGV14138150HA M1198397 SGV14148747HA M1199109 SGV14148788HA M1199049 SGV14150001HA M1199109 SGV14150005HA M1199109 SGV14150007HA M1199109 SGV14150037HA M1199109 SGV14150039HA M1199109 SGV14150041HA M1199109 SGV14150042HA M1199109 SGV14150043HA M1199109 SGV14150044HA M1199109 SGV14150045HA M1199109 SGV14150051HA M1199109 SGV14150060HA M1199109 SGV14150064HA M1199109 SGV14150068HA M1199109 SGV14150071HA M1199109 SGV14150074HA M1199109 SGV14150075HA M1199109 SGV14150079HA M1199109 SGV14150170HA M1199109 SGV14150179HA M1199109 SGV14150180HA M1199109 SGV14150182HA M1199109 SGV14150194HA M1199109 SGV14150195HA M1199109 SGV14150197HA M1199109 SGV14150203HA M1199109 SGV14150204HA M1199109 SGV14150207HA M1199109 SGV14150208HA M1199109 SGV14159469HA M1199109 SGV14159471HA M1199109 SGV14159472HA M1199109 SGV14159484HA M1199109 SGV14159488HA M1199109 SGV14159489HA M1199109 SGV141594 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2617-2014%22
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