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GE Medical Systems China Co., Ltd. recalls GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Recalled September 5, 2018 · FDA recall Z-2954-2018 · GE Medical Systems China
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. · FDA Class II
Units
310 units
Sold at
Worldwide
Description
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.
Product
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Manufacturer(s)
GE Medical Systems China Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →