Aisys CS2 with Et Control recall
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Why was Aisys CS2 with Et Control recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
- Product
- Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- Recalling firm
- Datex-Ohmeda, Inc.
- Quantity
- 7 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- September 23, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)