Anesthesia Gas Machine Recall: Breathing Circuit Misconnection Risk
Datex-Ohmeda is recalling Avance anesthesia gas machines worldwide due to a potential hazard if a patient's breathing circuit is incorrectly connected to the Auxiliary Common Gas Outlet port during setup.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recalls carry a minimum severity rating of 4 per established rules. No deaths or serious injuries are reported in the source text. This classification is Severe.
Plain-English summary
Datex-Ohmeda, Inc. is recalling the Avance anesthesia gas machine due to a potential hazard related to equipment connections. A patient's breathing circuit limb could be incorrectly connected to the Auxiliary Common Gas Outlet (ACGO) port during setup, creating a potential safety issue.
This recall affects 9,349 units of the Avance anesthesia gas machine, which have been distributed worldwide, including throughout the United States.
Medical personnel should verify that breathing circuit limbs are connected only to the appropriate connection points and not to the Auxiliary Common Gas Outlet. Facilities should review their setup procedures and contact Datex-Ohmeda for guidance on inspection and any recommended corrective actions.
The recalled product
- Product
- Avance. 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.
- Manufacturer
- Datex-Ohmeda, Inc.
- Affected units
- 9,349
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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