FDA Device recall Z-0412-2019
Aisys CS2 Anesthesia System
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of Aisys CS2 Anesthesia System by Ge Healthcare, citing upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to S….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0412-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-27 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
Reason
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
Identifiers
| code_info | Model Number, UDI Number, (Serial Number): 1011-9050-000, 010084068210229221APWX0132811180608, (APWX01328); 1011-…Model Number, UDI Number, (Serial Number): 1011-9050-000, 010084068210229221APWX0132811180608, (APWX01328); 1011-9050-000, 010084068210229221APWX0048411180208, (APWX00484); 1011-9050-000, 010084068210229221APWW0214911171214, (APWW02149); 1011-9050-000, 10084068210229221APWW0215011171214, (APWW02150); 1011-9050-000, 010084068210229221APWX0026111180118, (APWX00261); 1011-9050-000, 010084068210229221APWX0026211180118, (APWX00262); 1011-9050-000, 010084068210229221APWX0140911180618, (APWX01409); 1011-9050-000, 010084068210229221APWX0141011180618, (APWX01410); 1011-9050-000, 010084068210229221APWX0141111180618, (APWX01411); 1011-9050-000, 010084068210229221APWX0141211180618, (APWX01412); 1011-9050-000, 010084068210229221APWX0141311180618, (APWX01413); 1011-9050-000, 010084068210229221APWX0141411180618, (APWX01414); 1011-9050-000, 010084068210229221APWX0141511180618, (APWX01415); 1011-9050-000, 010084068210229221APWX0141611180618, (APWX01416); 1011-9050-000, 010084068210 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0412-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.