FDA-Device2018-09-05Class II
GE 9100c NXT 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
401 units
Manufactured in
National Hi-Tech, No. 19 Changjiang Road; Dev. Zone, Wuxi, N/A, China
Products
GE 9100c NXT anesthesia systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2956-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief