Aisys CS2 with Et Control recall (Datex-Ohmeda, Inc.)
Medical deviceClass IIOngoing
Summary: Datex-Ohmeda, Inc. is recalling 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.
What is being recalled
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution.
How to tell if yours is affected
Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3191-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 30, 2026 |
| Reported | September 23, 2026 |
| Company | Datex-Ohmeda, Inc. |
| Company location | Madison, WI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 units |
More recalls from Datex-Ohmeda, Inc. · all medical device recalls · recalls from July 2026