GE Healthcare Recalls Aisys CS2 Anesthesia Devices Due to Bolus Issue
GE Healthcare is recalling Aisys CS2 and upgraded Aisys anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential safety issue with anesthetic delivery, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare has identified a potential safety issue affecting Aisys CS2 and upgraded Aisys anesthesia devices. The issue involves a momentary, self-correcting anesthetic agent bolus that can occur when the devices are used with 21% oxygen.
The recall covers 5,496 units of the affected devices. These units were distributed across numerous U.S. states and territories, as well as in many international locations, including countries in Europe, Asia, the Americas, and the Middle East.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this issue. Users of these devices should monitor for official guidance from GE Healthcare or the FDA regarding necessary corrective actions.
The recalled product
- Product
- GE Healthcare, Aisys CS2 anesthesia..
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 5,496
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Medical Systems, LLC 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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