Aisys Carestation Anesthesia System — recall 59349
Health Canada — Medical Devices · Canada · 2019-04-18 · Type II
As described by Health Canada — Medical Devices: Aisys Carestation Anesthesia System - Main Unit, Aisys CS2 Anesthesia Machine Main Unit (2019-03-17)
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Reported risk: Aisys CS2 anesthesia devices with software version 11 and Aisys anesthesia devices upgraded to software version 11 can, on rare occasions involving a non-typical workflow, fail to deliver the set agent concentration in end tidal control (ET control) if ET control is automatically exited while a pause gas flow procedure is in progress. Following the auto-exit in this situation, if the clinician re-enters ET control, agent delivery will not function. Fresh gas control delivery mode is not affected.
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