FDA Device recall Z-3191-2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 by Datex Ohmeda, citing anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 1….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3191-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-30 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Datex Ohmeda |
| Distribution | US |
Product
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Reason
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.
Identifiers
| code_info | Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Datex Ohmeda
- Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field repla…
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M…
FDA Device · Class I · 2026-06-24 · Datex Ohmeda - Giraffe Stand-alone Infant Resuscitation System
FDA Device · Class I · 2026-06-24 · Datex Ohmeda
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3191-2026%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.