Aespire 7100 Anesthesia Machines Recalled for Breathing Circuit Misconnection
Datex-Ohmeda is recalling 20,097 Aespire 7100 series anesthesia machines because a patient breathing circuit can be mistakenly connected to the wrong outlet (ACGO port) instead of the intended connection point.
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: This is an FDA Class I medical device recall, which per the severity rubric never scores below 4. No deaths, serious injuries, or illnesses are reported in the source material, so this scores as Severe (4) rather than Critical (5).
Plain-English summary
Datex-Ohmeda, Inc. is recalling 20,097 units of Aespire 7100, Aespire 7100 (Variant), and Aespire 7100 S/5 Protiva anesthesia gas machines. These machines are designed to deliver general inhalation anesthesia and provide ventilatory support during medical procedures.
The recall addresses a potential issue where a patient breathing circuit limb can be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port rather than the correct connection point. All serial numbers of these models are potentially affected when configured with the AGCO option.
The machines have been distributed worldwide, including throughout the United States and to numerous other countries. The FDA classified this as a Class I recall, indicating a serious potential hazard.
The recalled product
- Product
- Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are 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…
- Manufacturer
- Datex-Ohmeda, Inc.
- Affected units
- 20,097
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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