GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Medical device recall Z-2954-2018. 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
- 310 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 Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
310 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(a) 620, A1: Serial Numbers: SM618060027MA SM618160055MA SM618160049MA SM618120029MA SM618120027MA SM618120026MA SM618120028MA SM618190086MA SM618190098MA SM618190095MA SM618190094MA SM618190093MA SM618190096MA SM618190097MA SM618060028MA…
Every code shown here, 1,989 characters
(a) 620, A1: Serial Numbers: SM618060027MA SM618160055MA SM618160049MA SM618120029MA SM618120027MA SM618120026MA SM618120028MA SM618190086MA SM618190098MA SM618190095MA SM618190094MA SM618190093MA SM618190096MA SM618190097MA SM618060028MA SM618060025MA SM618060024MA SM618060023MA SM618060019MA SM618060015MA SM618060016MA SM618060017MA SM618130008WA SM618130010WA SM618130009WA SM618130007WA SM618130011WA SM618130012WA SM618200003WA SM618200002WA SM618200004WA SM618200005WA SM618120030MA SM618120031MA SM618120036MA SM618160011MA SM618160010MA SM618120032MA SM618120034MA SM618120033MA SM618120035MA SM618120037MA SM618100002WA SM618100003WA SM618100004WA SM618100001WA SM618100005WA SM618100006WA SM618100007WA SM618100008WA SM618100009WA SM618100010WA SM618100011WA SM618100012WA SM618160071MA SM618210084WA SM618070008WA SM618070009WA SM618070010WA SM618070007WA SM618070011WA SM618070006WA SM618200028WA SM618200027WA SM618150006WA SM618150007WA SM618150005WA SM618150003WA SM618150004WA SM618160092WA SM618080005WA SM618080003WA SM618080004WA SM618050010WA SM618050009WA SM618080006WA SM618210028WA SM618210026WA SM618210027WA SM618150018WA SM618150019WA SM618150008WA SM618150009WA SM618150010WA SM618150011WA SM618150012WA SM618150043WA SM618150044WA SM618150045WA SM618150042WA SM618150046WA SM618230034WA SM618230035WA SM618240002WA SM618230033WA SM618230036WA SM618230037WA SM618240003WA SM618240004WA SM618240005WA SM618240006WA SM618210020WA SM618210021WA SM618210018WA SM618210019WA SM618210022WA SM618210005WA SM618210006WA SM618210007WA SM618210004WA SM618210008WA SM618160094WA SM618160095WA SM618160093WA SM618160096WA SM618160097WA SM618160098WA SM618160099WA SM618160100WA SM618160101WA SM618150024WA SM618150025WA SM618150026WA SM618150023WA SM618150027WA SM618150028WA SM618150029WA SM618150030WA SM618150031WA SM618150032WA SM618070005WA SM618060002WA SM618150015WA SM618150016WA SM618150013WA SM618150014WA SM618150017WA SM618150020WA SM618150021WA SM618150022WA…
FDA’s list runs to 18,481 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 18,481 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
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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.