GE 9100c NXT anesthesia systems recalled for gas switch defect
GE Medical Systems is recalling 401 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 is classified as FDA Class II and involves a risk of harm (hypoxia) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling 401 GE 9100c NXT anesthesia systems distributed worldwide. The recall addresses a defect in the auxiliary gas switch on systems equipped with the Auxiliary Common Gas Outlet (ACGO) or the Aux O2 + Air function.
On affected systems, the auxiliary gas switch may unexpectedly switch from the ACGO position or the Aux O2 + Air position back to the circle position. This unexpected change in switch position could lead to hypoxia in patients.
Healthcare providers should check their inventory for the specific serial numbers listed in the recall notice and contact GE Medical Systems for instructions on how to proceed with the recall.
The recalled product
- Product
- GE 9100c NXT anesthesia systems
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Affected units
- 401
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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