GE Healthcare Recalls Aisys Carestation Anesthesia Devices Due to Bolus Issue
GE Healthcare is recalling Aisys Carestation 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 in a medical device, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
GE Medical Systems, LLC is recalling 1,294 units of the GE Healthcare Aisys Carestation anesthesia device. The recall involves Aisys CS2 and upgraded Aisys anesthesia devices.
The recall is due to a potential safety issue where a momentary, self-correcting anesthetic agent bolus may occur when using 21% oxygen. The affected devices were distributed across all 50 U.S. states, the District of Columbia, Puerto Rico, and numerous international locations.
Healthcare providers should contact GE Healthcare for instructions on how to address the issue. The source text does not specify a specific consumer action beyond the recall notification.
The recalled product
- Product
- GE Healthcare, Aisys Carestation.
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 1,294
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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