Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet
Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class I recall, but no deaths, injuries, or illnesses have been reported. The hazard is potential—the source describes a possible misconnection scenario rather than confirmed harm. When a Class I recall involves no reported illnesses and the hazard is theoretical, the rubric permits a maximum severity score of 3 (High).
Plain-English summary
The Datex-Ohmeda Amingo anesthesia system is subject to a Class I recall due to a potential design issue that may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the proper connection point.
The issue affects all 77 units of the Amingo systems configured with the AGCO option, regardless of serial number or production lot. These devices are distributed worldwide, including across the United States and 79 other countries.
No injuries or illnesses have been reported in connection with this recall. However, the potential for misconnection exists due to the device design, and the manufacturer is addressing this issue through the recall.
Clinical staff and customers should verify their breathing circuit connections are properly positioned to the intended outlet, not the ACGO port. Contact Datex-Ohmeda, Inc. for specific guidance on correcting or managing affected units.
The recalled product
- Product
- Amingo. OUS only.
- Manufacturer
- Datex-Ohmeda, Inc.
- Hazard
- breathing-circuit-misconnection
Distribution
Distributed nationwide across the United States.
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