GE Carestation 30 Anesthesia Systems Recalled for Gas Switch Defect
GE Medical Systems is recalling 252 Carestation 30 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.
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 involves a risk-of-harm product (anesthesia system) where the potential for hypoxia is a serious health risk, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling 252 units of the GE Carestation 30 anesthesia system. The recall covers systems distributed worldwide that are equipped with either the Auxiliary Common Gas Outlet (ACGO) or the Aux O2 + Air function.
The recall is due to a potential defect where the auxiliary gas switch may unexpectedly switch from the ACGO or Aux O2 + Air position back to the circle position. This unintended change in switch position could lead to hypoxia in patients.
Healthcare facilities and users should check their equipment against the list of affected serial numbers provided by the manufacturer. If a system is affected, users should follow the instructions provided by GE Medical Systems for corrective action.
The recalled product
- Product
- GE Carestation 30 anesthesia systems
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Affected units
- 252
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by GE Medical Systems China Co., Ltd. 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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