Aisys CS2 Anesthesia Machine Breathing Circuit Misconnection Hazard
Datex-Ohmeda's Aisys CS2 anesthesia machine may pose a risk if a patient breathing circuit limb is mistakenly connected to the Auxiliary Common Gas Outlet port. Ninety-two units worldwide are affected in this FDA Class I recall.
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: FDA Class I classification for medical devices establishes a minimum severity level of 4 per the recall rubric. Although no deaths or injuries have been reported in the source, the FDA's Class I designation reflects a reasonable probability of serious harm if the identified breathing circuit misconnection defect occurs during patient anesthesia.
Plain-English summary
The Aisys CS2 with Et Control is an anesthesia gas delivery machine manufactured by Datex-Ohmeda, Inc. designed to provide general inhalation anesthesia and ventilatory support to patients under professional anesthesiology care. Datex-Ohmeda has issued a Class I recall due to a potential safety issue involving incorrect breathing circuit connections.
The specific hazard is that a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port rather than the intended port, potentially disrupting proper anesthesia gas delivery. All serial numbers of the Aisys CS2 device configured with the AGCO option are potentially affected.
This recall impacts 92 units of the device that have been distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, Africa, and the Americas, as well as island nations and territories globally.
The recalled product
- Product
- Aisys CS2 with Et Control. 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
- 92
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.
See all 11 products in this recall →Related recalls
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