Aisys (Datex-Ohmeda) – Gas Outlet Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Brand
Datex-Ohmeda, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
GTIN: 00840682102292. Model Number: 1011-9000-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.
Datex-Ohmeda, Inc. is recalling Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat due to Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Recommended Action
Per FDA guidance
GE Healthcare notified consignees on about 07/12/2024 via letter. Consignees were instructed to ensure all potential users complete the Preoperative Checkout procedure in its entirety, as detailed in the URM, make sure that the breathing circuit is correctly connected, only connect an auxiliary manual breathing circuit to the ACGO port, place the included addendum with the URM and inspect all potentially affected devices for the presence of covers applied to the ACGO Port and ACGO Switch. Additionally, customers were requested to complete and return the response form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026