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

Medical DevicesSource: FDA (device) · Date: 2026-09-23

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Datex-Ohmeda, Inc.
Product
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution.
Recall initiated
2026-07-30
Code info
Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
Product quantity
7 units
Voluntary mandated
Voluntary: Firm initiated
City
Madison
State
WI
Country
United States
Event id
99649
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