FDA Recall
Terminated
GE 9100c NXT anesthesia systems
Recall: Z-2956-2018
·
Initiated July 24, 2018
Recall
- Recall Number
- Z-2956-2018
- Event Number
- 80693
- Firm
- GE Medical Systems China Co., Ltd. National Hi-Tech No.
- FEI Number
- 3003513129
- Product Code
- BSZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 24, 2018
- Terminated
- December 16, 2020
- Address
- 19 Changjiang Road, Dev. Zone Wuxi China
Description
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.
Action
The firm issued a medical device correction notice on 07/24/2018. The notice explained the issue and provided safety instructions should the use observe a switch change. The units will be corrected. Questions or concerns may contact 1-800-437-1171 or the local service representative.
Distribution
Worldwide
Quantity
401 units