Device recall
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- Recall number
- Z-3191-2026
- Event id
- 99649
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Datex-Ohmeda, Inc.
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Jul 30, 2026
- Center classification date
- Sep 16, 2026
- Product code
- BSZ
- Device type
- Gas-Machine, Anesthesia
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 7 units
- Code info
- Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
- Distribution
- Worldwide - US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K172045
- Location
- Madison, WI, United States