Aespire 7900 Anesthesia Gas Machine Recalled Over Breathing Circuit Misconnection Risk
Datex-Ohmeda has recalled 12,036 Aespire 7900 anesthesia gas machines worldwide due to potential risk of patient breathing circuit being mistakenly connected to the Auxiliary Common Gas Outlet port.
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 FDA has classified this as a Class I recall, which establishes a minimum severity of 4 per the severity rubric. Although no reported incidents or illnesses have been documented, the potential for serious patient harm from improper anesthesia delivery during a critical medical procedure justifies the Severe classification.
Plain-English summary
Datex-Ohmeda, Inc. has recalled the Aespire 7900 anesthesia gas machine, a device used to provide general inhalation anesthesia and ventilatory support during medical procedures. The recall affects 12,036 units distributed worldwide, including across the US and numerous international markets.
The recall has been issued because of a potential hazard: if a patient's breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the correct connection point, improper anesthesia delivery could result. This misconnection could lead to patient harm during anesthesia administration.
The Aespire 7900 is used only by medical professionals trained in administering general anesthesia. All serial numbers of this device with the AGCO option are potentially affected, regardless of model or lot number. The device bears GTIN 00840682102261 and model number 1009-9012-000.
Anesthesia professionals should verify that patient breathing circuits are connected to the correct outlet before use. Healthcare facilities should contact Datex-Ohmeda for guidance on mitigation or device replacement.
The recalled product
- Product
- Aespire 7900. 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
- 12,036
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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