Aisys recall
Datex-Ohmeda, Inc. recalled Aisys on September 23, 2026 because of anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. It was sold nationwide.
Why it was recalled
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.
What's recalled
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Quantity: 475 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Datex-Ohmeda, Inc., Madison, WI
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide - US Nationwide distribution. - Status
- Ongoing
- Recall number
- Z-3189-2026
- Source
- U.S. Food and Drug Administration
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