Use cautionMedical device recall · FDA · Published July 30, 2026
Datex-Ohmeda Aisys Anesthesia System Recall: Risk of Interrupted Anesthetic Delivery
Datex-Ohmeda recalls Aisys anesthesia systems with specific part numbers due to risk of automatic transition to Alternate O2 control, which may interrupt anesthetic delivery and require clinician intervention to prevent decreased anesthetic effect.
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.
✎ GovInfoNow plain-language explainer
Datex-Ohmeda is recalling Aisys anesthesia systems with part number 1011-9050-000 because certain electronic gas mixer assemblies can automatically switch to Alternate O2 control. This may interrupt anesthetic delivery, requiring a clinician to manually intervene to prevent the patient from experiencing decreased anesthetic effects. Read more at govinfonow.com/recall/1134671-datex-ohmeda-aisys-anesthesia-system-recall-risk-of-interrupted-anesthetic.
“Datex-Ohmeda Aisys Anesthesia System Recall: Risk of Interrupted Anesthetic Delivery.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134671-datex-ohmeda-aisys-anesthesia-system-recall-risk-of-interrupted-anesthetic. Based on FDA recall #Z-3189-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3189-2026%22&limit=1).
The FDA announced on July 30, 2026, that Datex-Ohmeda Inc. is recalling Aisys anesthesia systems with part number 1011-9050-000 due to a hazard involving automatic transitions to Alternate O2 control. This issue interrupts anesthetic agent delivery and requires clinician intervention to prevent decreased anesthetic effect in patients.
How to tell if you have it
Brand: Datex-Ohmeda
Product: Aisys, Datex-Ohmeda anesthesia system
Part Number: 1011-9050-000
UDI-DI: 00840682102292
Units affected: 475
The hazard
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control, delivering 100% O2 and initiating alarms. When this occurs, anesthetic agent delivery is interrupted and requires clinician intervention; without it, the patient may experience decreased anesthetic agent effect.
Context
GovInfoNow's records show Datex-Ohmeda Inc has 8 other recalls on record since 2017-12-08. Other recent recalls of similar products include Draeger Vapor 3000 Anesthetic Vaporizer Recall (2025-11-24), Mindray Isoflurane V90 Vaporizer Recall (2025-10-20), and Draeger Atlan A350 Anesthesia Workstation Recall (2026-05-07).
How to tell if you have this one
Check for the part number 1011-9050-000 on the Aisys anesthesia system. The system has specific serial numbers listed in the recall notice, including APWC01722 and other codes starting with APW.
Brand
Datex-Ohmeda
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000; Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3189-2026 (July 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3189-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.