Datex-Ohmeda recalls Aisys anesthesia machines due to risk of patient injury from incorrect gas circuit connections. All units with Auxiliary Common Gas Outlet (ACGO) option are 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 all Aisys anesthesia machines that have the Auxiliary Common Gas Outlet (ACGO) option. This could cause serious harm if a patient's breathing circuit is incorrectly connected to the ACGO port during surgery.
If a patient's breathing circuit is mistakenly connected to the ACGO port instead of the correct gas outlet, it could deliver the wrong type of anesthesia gas. This might cause inadequate anesthesia or respiratory problems during surgery.
Medical professionals using the Aisys anesthesia machines are most at risk. All units with the ACGO option are affected, regardless of serial number or model.
Check if your Aisys machine has the Auxiliary Common Gas Outlet (ACGO) option. All units with this feature are affected, and no specific serial numbers or model numbers are excluded.
Verify that the patient's breathing circuit is connected to the correct gas outlet, not the ACGO port.
Reach out to Datex-Ohmeda for guidance on proper setup if you're unsure about your machine's configuration.
No, only Aisys machines with the Auxiliary Common Gas Outlet (ACGO) option are affected. All units with this feature are included, regardless of serial number or model.
Check if your Aisys machine has the Auxiliary Common Gas Outlet (ACGO) option. All units with this feature are affected, and no specific serial numbers or model numbers are excluded.
No, but you should verify the connection setup to ensure the patient's breathing circuit is connected to the correct gas outlet. Contact Datex-Ohmeda for guidance if needed.
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-0081-2025 — Datex-Ohmed: Aisys Datex-Ohmed: Aisys Hello, I own a Datex-Ohmed: Aisys that is covered by recall Z-0081-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
