GE Healthcare, Avance, Avance CS2, Amingo.
Medical device recall Z-0755-2017. Published in FDA’s Enforcement Report on Dec 21, 2016.
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 Dec 21, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 23,098 (US = 8,711; OUS = 14,387) 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?
GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Avance, Avance CS2, Amingo.
23,098 (US = 8,711; OUS = 14,387), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
FMI 34079 Initial Consignee List Mfg. Lot or Serial # ANBM00775 ANBM00776 ANBM00779 ANBN00775 ANBR01060 APKS01034 APKT00107 APKT02107 APKU00169 APKU00170 APKU00171 APKU01696 APKU01697 APKU01698 APKU01699 APKV00455 APKV00456 APKV00457…
Every code shown here, 1,994 characters
FMI 34079 Initial Consignee List Mfg. Lot or Serial # ANBM00775 ANBM00776 ANBM00779 ANBN00775 ANBR01060 APKS01034 APKT00107 APKT02107 APKU00169 APKU00170 APKU00171 APKU01696 APKU01697 APKU01698 APKU01699 APKV00455 APKV00456 APKV00457 APKV00458 ANBH00259 ANBP00673 ANBP01851 ANBP02120 ANBP02121 APKS01352 APKS01353 APKS01354 APKS01355 APKS01356 APKT02322 APKT02323 APKT02324 APKT02325 APKT02326 APKV01600 APKV01601 APKV01602 APKV01554 APKV01555 APKV01556 APKV01557 APKV01558 APKV01559 APKV01560 APKV01561 APKV01562 APKV01198 APKV01199 APKV01200 APKV01201 ANBQ01418 ANBQ01419 ANBQ01420 ANBQ01421 ANBR01342 APKV00450 APKV00451 ANBM00230 ANBM00273 ANBM00497 ANBR00289 ANBR00290 ANBR00291 ANBR00292 ANBR00293 ANBR00294 ANBR00295 APKV01885 APKV01210 APKV01211 APKV00205 APKV00206 APKV00207 APKV00208 APKV00209 APKV00210 APKV00211 APKV00212 APKV00213 APKV00214 APKU00134 APKU00135 ANBQ01520 ANBQ01521 ANBQ01522 ANBQ01523 ANBQ01524 ANBQ02209 ANBQ02210 ANBQ02211 ANBQ02212 ANBQ02213 ANBS00535 ANBR01078 ANBR01079 ANBR01080 ANBK00957 APKU02425 APKU02426 APKU02427 APKU02428 APKU02429 APKU02430 APKU02431 APKU02432 ANBL01069 ANBP01486 ANBP01487 ANBP01488 ANBP01489 ANBP01490 ANBP01491 ANBP01492 ANBP01493 ANBN00773 ANBN00774 ANBN00791 ANBN00797 ANBN00798 ANBN00799 ANBN00800 ANBN00634 ANBN00921 ANBN00922 ANBN00923 ANBN00925 ANBN00926 ANBN00927 ANBN00928 ANBN00929 ANBN00930 ANBN00931 ANBN00932 ANBN00945 ANBN00946 ANBP01359 APKU01872 ANBR01053 ANBR01054 APKV01598 ANBN00633 ANBQ01015 ANBP00529 ANBP00530 ANBP00531 ANBQ01480 ANBQ01484 ANBQ01965 ANBQ01966 ANBS00304 ANBS00305 APKT00144 APKT02991 ANBN01391 ANBP01331 ANBN01672 ANBN01673 APKT02494 APKT02495 APKT02496 APKU00698 APKU00699 APKU00700 APKS01106 APKS01107 APKS01108 APKS01109 APKS01110 ANBJ01449 ANBJ01450 ANBK00679 ANBK00680 ANBM00539 ANBP01113 ANBP01114 ANBP01115 ANBP01116 ANBP01117 ANBP01118 ANBP01119 ANBQ01751 ANBR00248 APKT00754 APKT02383 APKV00943 APKV00944 APKV01877 APKV01878 ANBP01648 ANBP01649 ANBK00674 ANBK00743 ANBK00953 ANBN00512…
FDA’s list runs to 251,180 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.
USA ( nationwide) Distribution including Puerto Rico and DC. and to the countries of Australia AUSTRIA Azerbaijan Bahrain Bangladesh Barbados Belarus Belgium BOLIVIA BOSNIA-HERZEGOVINA Brazil BRUNEI BULGARIA Canada CHILE China COLOMBIA COSTA RICA Croatia Cyprus Czech Republic Denmark ECUADOR Egypt Estonia Ethiopia Finland FRANCE Georgia GERMANY Ghana Gibraltar GREECE HONG KONG HUNGARIA Iceland India Indonesia IRAQ Ireland Israel ITALY JAPAN JORDAN KAZAKHSTAN Kenya KOREA, REPUBLIC OF Kuwait Latvia Lebanon Libyan Arab Jamahiriya LITHUANIA MACEDONIA MALAYSIA Malta Mexico MOLDOVA MOROCCO NAMIBIA Netherlands New Zealand Nicaragua Nigeria NORWAY Oman Pakistan Panama PARAGUAY PERU PHILIPPINES Poland PORTUGAL Qatar ROMANIA Russian Federation Saudi Arabia Serbia SERBIA-MONTENE Singapore Slovakia SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN Thailand Tunisia TURKEY Ukraine United Arab Emirates UNITED KINGDOM Uruguay UZBEKISTAN Venezuela VietNam Yemen
The states and territories these words name
- District of Columbia
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Nov 3, 2016.
- FDA classified it on Dec 14, 2016.
- FDA’s Enforcement Report published it on Dec 21, 2016.
- FDA terminated it on Sep 17, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- 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 251,180 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.