Datex-Ohmeda recalls Aisys CS2 anesthesia machines with Et Control due to risk of patient injury if breathing circuit limb is mistakenly connected to Auxiliary Common Gas Outlet port. All units with AGCO option affected.
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Datex-Ohmeda is recalling Aisys CS2 anesthesia machines with Et Control because a mistake in connecting a patient's breathing circuit could cause injury. This affects all units with the AGCO option, which are used by medical professionals in hospitals.
If a patient's breathing circuit limb is accidentally connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the correct port, it could cause improper gas delivery and potentially lead to patient injury.
Medical professionals using the Aisys CS2 anesthesia machines in hospitals are most at risk. All units with the Auxiliary Common Gas Outlet (AGCO) option are affected, regardless of serial number.
Check if your machine has the AGCO option. All Aisys CS2 with Et Control units, including those with serial numbers, are affected. The model number is 1011-9055-000.
Verify that the patient's breathing circuit limb is connected to the correct port, not the Auxiliary Common Gas Outlet (ACGO) port.
No, all Aisys CS2 with Et Control units with the AGCO option are affected, regardless of serial number or model.
All units with the model number 1011-9055-000 and the AGCO option are affected. Check the machine's documentation for the AGCO option.
Ensure the patient's breathing circuit limb is connected to the correct port, not the Auxiliary Common Gas Outlet (ACGO) port.
We’ve drafted a message you can send Datex-Ohmed: Aisys to request your refund or repair — edit it as you like.
Subject: Recall Z-0083-2025 — Datex-Ohmed: Aisys Datex-Ohmed: Aisys Hello, I own a Datex-Ohmed: Aisys that is covered by recall Z-0083-2025 from Datex-Ohmed: Aisys. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
