FDAJuly 30, 2026
Datex-Ohmeda Aisys Anesthesia System Recall Over Electronic Gas Mixer Assembly
FDA published this notice on July 30, 2026 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- July 30, 2026
- Recall class
- Class II
- Reason given by the agency
- 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.
- Distribution
- Worldwide - US Nationwide distribution.
- Official source
- the notice at its source
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Source: FDA.