Z-0083-2025Class I

Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia...

Name: Z-0083-2025 Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia...
Creator: Datex-Ohmeda, Inc.
Published: 2024-07-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2024-07-12 / Open, Classified / root cause: design

FDA source

Datex-Ohmeda, Inc. began a recall of Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be... on 2024-07-12. FDA classified it as Class I and gives the reason as "Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0083-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-07-12
Posted: 2024-10-18
Recalling firm: GE Healthcare
Product: Aisys CS2 with Et Control. 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.
Product code: QSF Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
Reason for recall: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 92 units
Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.
Product codes and lots: GTIN: 00195278588128. Model Number: 1011-9055-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0083-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0074-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0075-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0076-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0077-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0078-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0079-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0080-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0081-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0082-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0083-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0084-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18

Product code QSF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)