medical MODERATE Updated 2026-09-23

Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, P

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Recalled Product

Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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