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U.S. Department of Health and Human Services

Class 2 Device Recall GE 9100c NXT

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  Class 2 Device Recall GE 9100c NXT see related information
Date Initiated by Firm July 24, 2018
Create Date August 30, 2018
Recall Status1 Terminated 3 on December 16, 2020
Recall Number Z-2956-2018
Recall Event ID 80693
510(K)Number K151570  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product GE 9100c NXT anesthesia systems
Code Information Serial 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Recalling Firm/
GE Medical Systems China Co., Ltd.
National Hi-Tech
No. 19 Changjiang Road; Dev. Zone
Wuxi China
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 401 units
Distribution Worldwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.