Reported Sep 5, 2018 · Terminated

GE 9100c NXT anesthesia systems

GE Medical Systems China Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Medical Systems China Co., Ltd. · National Hi-Tech · Wuxi, N/A · N/A

Is this the product you have?

  • GE 9100c NXT anesthesia systems
Lot codes and dates
  • Serial Numbers

    401 of 401 codes

    • 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
Amount recalled
401 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 16, 2020 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.