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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port."
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.
- Affected units
- 77
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Datex-Ohmeda, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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