Aisys CS2 Anesthesia System — Class II medical device recall Z-0412-2019
Terminated recall by GE Healthcare, LLC, reported 2018-11-21, distributed nationwide. Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do
| Recall number | Z-0412-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-09-27 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2021-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CN, CO, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, IE, IL, IN, IS, IT, JO, JP, KR, KW, MX, NG, NL, NO, NZ, PE, PT, QA, RU, SA, SE, SG, TH, TR, TW, VN, ZA |
| Quantity | 4,207 units |
| UPC / GTIN / UDI-DI | 00010911180104, 00012311180104, 00013011180104, 00014611180105, 00015311180105, 00016011180105, 00017711180105, 00018111180115, 00019811180115, 00020411180115, 00021111180115, 00022711180116, 00023411180116, 00024111180116, 00025811180116, 00026311180118, 00027011180118, 00028711180118, 00029411180118, 00030011180118, 00030211180123, 00031911180123, 00032611180123, 00033311180123, 00034011180123 and 213 more |
| NDC | 01011-9050-00 |
| Serial numbers | 1011-9050-000, 2097675-001-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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0412-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.