FDA-Device2018-09-05Class II
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
GE Medical Systems China Co., Ltd.
Hazard
On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.
Sold states
Worldwide
Affected count
310 units
Manufactured in
National Hi-Tech, No. 19 Changjiang Road; Dev. Zone, Wuxi, N/A, China
Products
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2954-2018Don't want to check this manually?
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