Medical device licence · 92220 · Class 3
AISYS CS2
Yes: licensed in Canada
Licence status Issued (active); first licensed October 31, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92220
- Licence holder
- Datex-Ohmeda, Inc.Madison, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 31, 2013
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AISYS CS2 ANESTHESIA MACHINE MAIN UNIT
- AISYS CS2 OPTIONAL ET CONTROL KIT
- AISYS CS2 OPTIONAL SOFTWARE
- AISYS CS2 SYSTEM SOFTWARE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “aisys”. A notice may cover another product or only some lots: read it to see what it covers.
- Aisys™ CS² and Carestation™August 21, 2026 · Anaesthesiology · Performance · Type II
- Aisys, Avance, and Aespire Anesthesia MachinesJuly 2, 2026 · Anaesthesiology · Performance · Type II
- Aisys Cs2June 13, 2022 · Anaesthesiology · Performance · Type II
- Aisys Cs2June 13, 2022 · Anaesthesiology · Performance · Type II
- Aisys CS2 Anesthesia Machine Main Unit (2020-09-29)October 23, 2020 · Medical devices · Medical devices · Type II
- Aisys Carestation and Aisys CS2 (2018-09-27)June 7, 2019 · Medical devices · Medical devices · Type II
- Aisys Carestation Anesthesia System - Main Unit, Aisys CS2 Anesthesia Machine Main Unit (2019-03-17)April 18, 2019 · Medical devices · Medical devices · Type II
- AISYS CS2 ANESTHESIA MACHINE MAIN UNIT (2016-03-10)April 4, 2016 · Medical devices · Medical devices · Type II
- AISYS CS2 ANESTHESIA MACHINE MAIN UNIT (2016-02-18)March 4, 2016 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.