CLASS I ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Aisys CS2 with Et Control recalled by Datex-Ohmeda
Datex-Ohmeda is recalling Aisys CS2 with Et Control, distributed nationwide in the US. The recall was initiated on 12 Jul 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0083-2025
- FDA event ID
- 95045
- Recalling firm
- Datex-Ohmeda, Madison, WI
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Jul 2024
- FDA classified
- 18 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 12 Jul 2024 | Recall initiated by company | |
| 18 Oct 2024 | Classified by FDA | +98 days |
| 30 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 95045| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Aespire 100. This anesthesia gas machine is intended recalled | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Avance CS2 and Avance CS2 Pro recalled by Datex-Ohmeda | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Aisys CS2. This anesthesia gas machine is intended recalled | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Aisys. This anesthesia gas machine is intended to provide recalled | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Aespire 7100, 7100 (Variant) recalled by Datex-Ohmeda | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Avance. This anesthesia gas machine is intended to provide recalled | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Amingo. OUS only recalled by Datex-Ohmeda | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Aespire 7900. This anesthesia gas machine is intended to provide recalled | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Auxiliary Common Gas Outlet recalled by Datex-Ohmeda | Datex-Ohmeda | Other | Nationwide | |
| CLASS I | Aespire View recalled by Datex-Ohmeda | Datex-Ohmeda | Other | Nationwide |
More recalls from Datex-Ohmeda
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aisys, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |
| Device | CLASS II | Aisys CS2, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |
| Device | CLASS II | Et Control recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | Nationwide |
| Device | CLASS II | Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |
| Device | CLASS I | Panda Freestanding Warmer, Infant Radiant Warmer Product recalled | Datex-Ohmeda | Device Malfunction | WI |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |