FDA Device recall Z-1808-2014
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-CA…
- FDA Device
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of 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-CA… by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1808-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-23 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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".
Identifiers
| code_info | Mfg Lot or Serial # 6704120 6704126 6704128 6704129 6704132 6704133 6704134 6704138 6704143 6704146 6704147…Mfg Lot or Serial # 6704120 6704126 6704128 6704129 6704132 6704133 6704134 6704138 6704143 6704146 6704147 6704150 6704151 6704152 6705240 6705241 6705242 6705245 6705246 6705248 6705249 6705254 6705256 6705258 6705259 6705261 6705262 6705263 6705264 6705266 6705271 6705274 6705276 6705277 6705278 6705279 6705280 6705282 6705283 6705284 6705287 6705313 6705316 6705327 6705328 6705329 6705333 6705334 6705336 6705337 6705338 6705339 6705340 6705341 6705348 6705352 6705360 6706475 6706477 6706478 6706479 6706480 6706485 6706487 6706489 6706490 6707891 6707892 6707893 6707894 6707896 6707897 6707899 6707901 6707902 6707904 6707906 6707908 6707909 6707911 6707912 6707913 6707914 6707916 6707917 6707918 6707920 6707921 6707922 6707924 6707926 6707928 6707929 6707932 6707933 6707934 6707936 6707939 6707940 6707941 6707943 6707944 6707946 6707948 6707949 6707950 6707951 6707953 6707955 |
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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-1808-2014%22
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