Reported Oct 30, 2024 · Ongoing
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to…
Datex-Ohmeda, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datex-Ohmeda, Inc. · 3030 Ohmeda Dr · Madison, WI · 53718-6704
Is this the product you have?
- Aisys. 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.
- Lot codes and dates
- GTIN00840682102292
- Model Number1011-9000-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected
- Amount recalled
- 4,790 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Stop using this product now
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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