AisysRecalls & reported problems across all models
Datex-Ohmeda Inc · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Aisys model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,146
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 7
We found 2 models of Aisys by Datex-Ohmeda Inc in the FDA's device registry (GUDID). Together they are named in 2,146 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2018 and Sep 30, 2026 — classified as 17 injuries, 2,129 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (553 reports).
7 FDA recall records name at least one of these models by its device identifier, 6 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Aisys recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 30, 2026Open, Classified
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.
Z-3190-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jul 30, 2026Open, Classified
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.
Z-3189-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jul 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0083-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0082-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0081-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 1, 2022Terminated
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
Z-1389-2022 · Root cause: Process control · Recall details · FDA record ↗
- May 27, 2022Open, Classified
The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.
Z-1427-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported Aisys problems
Device problems
- Insufficient Flow or Under Infusion553
- Mechanical Problem294
- Therapeutic or Diagnostic Output Failure284
- Electrical /Electronic Property Problem147
- Unexpected Therapeutic Results139
- Power Problem118
- Failure to Run on Battery110
- Gas/Air Leak82
Patient problems
- No Clinical Signs, Symptoms or Conditions2,053
- No Patient Involvement44
- No Known Impact Or Consequence To Patient18
- No Consequences Or Impact To Patient14
- Low Oxygen Saturation8
- Cardiac Arrest3
- Insufficient Information3
- Burn(s)1
Aisys models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Aisys CS2Gas-machine, anesthesia5 recalls2,048 reports
- Aisys CS2 WITH ET CONTROLGas-machine, anesthesia2 recalls98 reports
Recent Aisys adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949938 ↗MalfunctionSep 30, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949909 ↗MalfunctionSep 30, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949825 ↗MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948890 ↗MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946774 ↗MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945096 ↗MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
It was reported that there was a malfunction resulting in insufficient oxygen during a case. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943852 ↗MalfunctionSep 29, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940226 ↗MalfunctionSep 29, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933124 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926633 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926590 ↗MalfunctionSep 28, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926568 ↗MalfunctionSep 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918739 ↗MalfunctionSep 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918423 ↗MalfunctionSep 25, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906256 ↗
Other Datex-Ohmeda Inc products
All Datex-Ohmeda Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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