Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GE 9100c NXT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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 Numbers: SPC18030143WA SPC18030140WA SPC18030141WA SPC18030142WA SPC18030144WA SPC18030145WA SPC18030146WA SPC18020071WA SPC18020070WA SPC18020068WA SPC18020069WA SPC18020072WA SPC18020073WA SPC18020074WA SPC18020075WA SPC18020076WA SPC18020077WA SPC18050293WA SPC18050294WA SPC18040287WA SPC18040285WA SPC18040286WA SPC18020097WA SPC18020095WA SPC18020096WA SPC18020094WA SPC18020098WA SPC18020099WA SPC18020100WA SPC18020101WA SPC18030102WA SPC18030103WA SPC18030104WA SPC18030105WA SPC18030106WA SPC18030107WA SPC18030108WA SPC18030109WA SPC18050297WA SPC18050299WA SPC18050295WA SPC18050296WA SPC18050298WA SPC18050303WA SPC18050300WA SPC18050301WA SPC18050302WA SPC18050304WA SPC18050313WA SPC18050312WA SPC18050310WA SPC18050311WA SPC18050329WA SPC18050330WA SPC18050331WA SPC18050332WA SPC18050333WA SPC18050334WA SPC18040259WA SPC18040260WA SPC18040261WA SPC18040258WA SPC18040262WA SPC18040265WA SPC18040263WA SPC18040264WA SPC18050292WA SPC18050290WA SPC18050291WA SPC18040288WA SPC18040289WA SPC18050324WA SPC18050327WA SPC18050314WA SPC18050326WA SPC18050325WA SPC18050335WA SPC18030113WA SPC18030110WA SPC18030111WA SPC18030112WA SPC18060454WA SPC18060450WA SPC18060451WA SPC18060452WA SPC18060453WA SPC18060455WA SPC18060456WA SPC18050411WA SPC18050412WA SPC18050413WA SPC18050410WA SPC18060414WA SPC18060415WA SPC18050376WA SPC18050379WA SPC18050374WA SPC18050375WA SPC18050377WA SPC18050378WA SPC18050383WA SPC18050380WA SPC18050381WA SPC18050382WA SPC18050384WA SPC18050385WA SPC18050386WA SPC18050387WA SPC18050388WA SPC18050389WA SPC18050390WA SPC18050391WA SPC18050392WA SPC18050393WA SPC18050394WA SPC18050395WA SPC18050373WA SPC18030122WA SPC18030119WA SPC18030123WA SPC18040222WA SPC18030118WA SPC18030120WA SPC18030121WA SPC18030124WA SPC18030125WA SPC18040279WA SPC18040277WA SPC18040278WA SPC18020079WA SPC18020081WA SPC18020080WA SPC18030138WA SPC18050362WA SPC18040215WA SPC18040219WA SPC18040232WA SPC18030188WA SPC18030189WA SPC18030177WA SPC18050343WA SPC18030198WA SPC18060435WA SPC18040217WA SPC18030179WA SPC18030150WA SPC18030148WA SPC18030149WA SPC18030151WA SPC18030183WA SPC18030184WA SPC18030185WA SPC18030202WA SPC18030201WA SPC18060441WA SPC18060434WA SPC18060432WA SPC18060430WA SPC18060431WA SPC18060447WA SPC18060448WA SPC18060449WA SPC18060457WA SPC18060458WA SPC18060459WA SPC18060460WA SPC18060461WA SPC18060462WA SPC18060463WA SPC18060464WA SPC18060465WA SPC18060466WA SPC18060467WA SPC18060468WA SPC18060469WA SPC18060470WA SPC18060471WA SPC18060472WA SPC18060473WA SPC18060474WA SPC18060475WA SPC18060476WA SPC18060477WA SPC18060478WA SPC18060479WA SPC18060444WA SPC18060445WA SPC18060446WA SPC18050402WA SPC18050403WA SPC18050404WA SPC18050405WA SPC18050406WA SPC18050344WA SPC18050345WA SPC18050349WA SPC18050350WA SPC18050351WA SPC18050352WA SPC18050353WA SPC18050354WA SPC18050355WA SPC18050359WA SPC18040231WA SPC18040239WA SPC18040214WA SPC18040213WA SPC18030190WA SPC18030192WA SPC18030194WA SPC18030195WA SPC18030196WA SPC18030197WA SPC18030205WA SPC18030206WA SPC18030117WA SPC18030126WA SPC18030116WA SPC18030127WA SPC18030128WA SPC18050321WA SPC18060480WA SPC18050356WA SPC18060442WA SPC18060443WA SPC18030193WA SPC18040211WA SPC18040212WA SPC18030115WA SPC18050399WA SPC18050400WA SPC18040234WA SPC18030162WA SPC18030147WA SPC18030131WA SPC18030132WA SPC18050348WA SPC18040218WA SPC18060436WA SPC18030178WA SPC18060433WA SPC18030161WA SPC18050361WA SPC18040233WA SPC18030129WA SPC18030130WA SPC18030159WA SPC18040220WA SPC18030203WA SPC18030158WA SPC18040209WA SPC18040208WA SPC18050346WA SPC18030191WA SPC18050357WA SPC18030199WA SPC18030200WA SPC18050342WA SPC18040230WA SPC18040247WA SPC18040243WA SPC18040240WA SPC18040241WA SPC18040242WA SPC18040244WA SPC18040245WA SPC18040246WA SPC18040248WA SPC18040249WA SPC18040250WA SPC18040251WA SPC18050316WA SPC18050317WA SPC18050318WA SPC18050315WA SPC18050319WA SPC18050320WA SPC18040227WA SPC18040228WA SPC18050347WA SPC18040236WA SPC18040237WA SPC18040238WA SPC18040229WA SPC18040226WA SPC18050360WA SPC18050401WA SPC18040216WA SPC18060440WA SPC18050397WA SPC18050398WA SPC18030204WA SPC18040235WA SPC18050358WA SPC18030180WA SPC18030186WA SPC18030181WA SPC18030182WA SPC18030187WA SPC18030152WA SPC18040270WA SPC18040266WA SPC18040267WA SPC18040268WA SPC18040269WA SPC18040271WA SPC18040272WA SPC18040273WA SPC18040274WA SPC18040275WA SPC18040276WA SPC18020085WA SPC18020086WA SPC18020083WA SPC18020084WA SPC18020087WA SPC18020088WA SPC18020089WA SPC18020090WA SPC18020091WA SPC18020092WA SPC18020093WA SPC18020065WA SPC18020055WA SPC18040281WA SPC18040280WA SPC18050367WA SPC18050366WA SPC18040284WA SPC18040282WA SPC18040283WA SPC18040225WA SPC18020059WA SPC18050341WA SPC18030137WA SPC18020066WA SPC18030153WA SPC18040221WA SPC18030139WA SPC18060483WA SPC18060482WA SPC18030157WA SPC18030155WA SPC18030156WA SPC18040210WA SPC18040207WA SPC18050372WA SPC18030135WA SPC18030133WA SPC18030134WA SPC18050328WA SPC18060423WA SPC18060424WA SPC18060421WA SPC18060422WA SPC18060425WA SPC18060426WA SPC18060427WA SPC18020056WA SPC18020057WA SPC18020058WA SPC18020082WA SPC18050408WA SPC18050409WA SPC18050322WA SPC18050323WA SPC18030136WA SPC18050364WA SPC18050305WA SPC18050306WA SPC18050307WA SPC18050308WA SPC18050309WA SPC18040224WA SPC18040223WA SPC18030164WA SPC18030165WA SPC18030166WA SPC18030163WA SPC18020060WA SPC18040256WA SPC18040255WA SPC18020064WA SPC18020061WA SPC18020062WA SPC18020063WA SPC18040254WA SPC18040253WA SPC18050407WA SPC18050396WA SPC18050363WA SPC18040257WA SPC18030154WA SPC18020078WA SPC18050371WA SPC18050370WA SPC18050338WA SPC18050337WA SPC18050339WA SPC18050336WA SPC18050340WA 
Recalling Firm/
Manufacturer		 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.
-
-