GE Carestation Anesthesia Systems Recalled for Gas Switch Defect
GE Medical Systems is recalling 310 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.
What this means for you
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 the hazard involves a risk of harm (hypoxia) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling 310 units of GE Carestation 620/650/650c, A1 and A2 anesthesia systems. These systems were distributed worldwide.
The recall is due to a potential defect in the Auxiliary Common Gas Outlet (ACGO) or Aux O2 + Air function. On affected systems, the auxiliary gas switch may unexpectedly switch from the ACGO or Aux O2 + Air position back to the circle position. This malfunction could lead to hypoxia in patients.
The recall covers specific serial numbers for the 620, 650, and 650c models, including A1 and A2 versions. Users should check their device serial numbers against the list provided by the manufacturer or the FDA to determine if their unit is affected.
The recalled product
- Product
- GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Affected units
- 310
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- (a) 620
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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