Aisys Carestation Anesthesia System - Main Unit, Aisys CS2 Anesthesia Machine Main Unit (2019-03-17)

Starting date:

March 17, 2019

Posting date:

April 18, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69622

Last updated: 2019-04-18

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  Reason
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  Affected products

Affected Products

1. Aisys Carestation Anesthesia System - Main Unit
2. Aisys CS2 Anesthesia Machine Main Unit

Reason

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.

Affected products