GE 9100c NXT anesthesia systems
Medical device recall Z-2956-2018. Published in FDA’s Enforcement Report on Sep 5, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 5, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 401 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE 9100c NXT anesthesia systems
401 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: SPC18030143WA SPC18030140WA SPC18030141WA SPC18030142WA SPC18030144WA SPC18030145WA SPC18030146WA SPC18020071WA SPC18020070WA SPC18020068WA SPC18020069WA SPC18020072WA SPC18020073WA SPC18020074WA SPC18020075WA SPC18020076WA…
Every code shown here, 1,990 characters
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…
FDA’s list runs to 5,629 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 24, 2018.
- FDA classified it on Aug 30, 2018.
- FDA’s Enforcement Report published it on Sep 5, 2018.
- FDA terminated it on Dec 16, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems China Co., Ltd., of Wuxi, China.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,629 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.