Recall Z-2956-2018— GE Medical Systems China Co., Ltd.

Name: FDA recall Z-2956-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-24

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems China Co., Ltd., initiated 2018-07-24, terminated 2020-12-16. It names one FDA 510(k) clearance: K151570. Product: GE 9100c NXT anesthesia systems. Reason: 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..

Recalling firm: GE Medical Systems China Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Terminated: 2020-12-16
Firm location: Wuxi, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K151570 — Carestation 620/650/650CDatex-Ohmeda, Inc.·cleared 2016-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE 9100c NXT anesthesia systems

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.