Hearth Record

GE Carestation 30 anesthesia systems

Medical device recall Z-2955-2018. Published in FDA’s Enforcement Report on Sep 5, 2018.

FDA’s own record, on accessdata.fda.gov

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.

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.

Source:

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

GE Carestation 30 anesthesia systems

252 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Serial Numbers: MF18045247 MF18045246 MF18055268 MF18055271 MF18055276 MF18055273 MF18055272 MF18055269 MF18055274 MF18055270 MF18055275 MF18055277 MF18045265 MF18045233 MF18045181 MF18035153 MF18065338 MF18035144 MF18035151 MF18025067…

Every code shown here, 1,996 characters

Serial Numbers: MF18045247 MF18045246 MF18055268 MF18055271 MF18055276 MF18055273 MF18055272 MF18055269 MF18055274 MF18055270 MF18055275 MF18055277 MF18045265 MF18045233 MF18045181 MF18035153 MF18065338 MF18035144 MF18035151 MF18025067 MF18025066 MF18065336 MF18035142 MF18065335 MF18055299 MF18055300 MF18055302 MF18055298 MF18055301 MF18055303 MF18055304 MF18055305 MF18055306 MF18055307 MF18055308 MF18055309 MF18055310 MF18055311 MF18055312 MF18055313 MF18055314 MF18055315 MF18055316 MF18055317 MF18055318 MF18055319 MF18055320 MF18055321 MF18055322 MF18055323 MF18055324 MF18055325 MF18055326 MF18065345 MF18045266 MF18055267 MF18055285 MF18045227 MF18045228 MF18045225 MF18045229 MF18045230 MF18045248 MF18045249 MF18045250 MF18045251 MF18045252 MF18045253 MF18045254 MF18045183 MF18045184 MF18045182 MF18045185 MF18045186 MF18045187 MF18045188 MF18045189 MF18045190 MF18045191 MF18035158 MF18035163 MF18035164 MF18035178 MF18035179 MF18035150 MF18045261 MF18045262 MF18045256 MF18045260 MF18045263 MF18045264 MF18045255 MF18045257 MF18045258 MF18045259 MF18065330 MF18065331 MF18065332 MF18065329 MF18045192 MF18045193 MF18035154 MF18045195 MF18045194 MF18035148 MF18045231 MF18045201 MF18045198 MF18045202 MF18045203 MF18045204 MF18045209 MF18045211 MF18035180 MF18035146 MF18035147 MF18045199 MF18035135 MF18065344 MF18045197 MF18045196 MF18045222 MF18045223 MF18045224 MF18045232 MF18035138 MF18035136 MF18035137 MF18035143 MF18035149 MF18035139 MF18065334 MF18035155 MF18035156 MF18035157 MF18035152 MF18045226 MF18045210 MF18065333 MF18065337 MF18035140 MF18035141 MF18035159 MF18035160 MF18045214 MF18045215 MF18045212 MF18045213 MF18045216 MF18045217 MF18045218 MF18045200 MF18015047 MF18015046 MF18045237 MF18045236 MF18045221 MF18045219 MF18045220 MF18055288 MF18045240 MF18045239 MF18035129 MF18035128 MF18035131 MF18035130 MF18025108 MF18025110 MF18025111 MF18025097 MF18025112 MF18025099 MF18025095 MF18025096 MF18025098 MF18025109 MF18025083 MF18025084 MF18025085 MF18025086…

FDA’s list runs to 2,787 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Source:

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.

Source:

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.
Source:

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.
Source:

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 2,787 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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