GE Medical Systems China Co., Ltd. recalls GE 9100c NXT anesthesia systems

Recall date

July 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2956-2018

FDA classification

Class II

Brand / firm

GE Medical Systems China Co., Ltd.

Sold / distributed

Worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE 9100c NXT anesthesia systems