Datex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
Datex-Ohmeda is recalling 140 Aisys CS2 anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a malfunction can interrupt anesthetic delivery, posing a risk of harm to patients if not immediately addressed by clinicians, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Datex-Ohmeda, Inc. is recalling 140 units of the Aisys CS2 anesthesia system (Part Number 1011-9055-000) due to a defect in certain electronic gas mixer assemblies. The affected units were distributed worldwide and across the United States.
The defect can cause the anesthesia delivery system to automatically transition to Alternate O2 control. In this mode, the system delivers 100% oxygen to the breathing system to enable continued ventilation and triggers audible and visual alarms. However, this transition interrupts the delivery of the anesthetic agent, requiring immediate clinician intervention to manage the patient's care.
If clinician intervention is not provided when the system transitions to Alternate O2 control, the patient may experience a decreased effect of the anesthetic agent. Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice and contact Datex-Ohmeda for instructions on corrective actions.
The recalled product
- Product
- Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
- Manufacturer
- Datex-Ohmeda, Inc.
- Affected units
- 140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00195278588128
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Datex-Ohmeda, Inc.
See all →- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- SevereGiraffe and Panda warmer blender knobs may deliver wrong oxygen concentration
FDA (Devices) · 2026-06-24
- SevereGiraffe infant resuscitation system may deliver wrong oxygen concentration
FDA (Devices) · 2026-06-24