GE Healthcare, Aisys, Amingo, Avance, and Avance CS2
Medical device recall Z-0009-2014. Published in FDA’s Enforcement Report on Oct 23, 2013.
- FDA Class I
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 Oct 23, 2013. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 10,263 (3,194 US, 7,069 OUS) 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), 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 recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
10,263 (3,194 US, 7,069 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # ANBR01060 ANAQ01557 ANBQ01421 ANBQ01418 ANBQ01419 ANBQ01420 ANBR01342 ANBR00292 ANBR00289 ANBR00293 ANBR00290 ANBR00291 ANBR00294 ANBR00295 ANBQ01522 ANBQ01520 ANBQ01524 ANBQ01521 ANBQ01523 ANBQ02209 ANBQ02212 ANBQ02213…
Every code shown here, 2,000 characters
Mfg Lot or Serial # ANBR01060 ANAQ01557 ANBQ01421 ANBQ01418 ANBQ01419 ANBQ01420 ANBR01342 ANBR00292 ANBR00289 ANBR00293 ANBR00290 ANBR00291 ANBR00294 ANBR00295 ANBQ01522 ANBQ01520 ANBQ01524 ANBQ01521 ANBQ01523 ANBQ02209 ANBQ02212 ANBQ02213 ANBQ02210 ANBQ02211 ANBS00535 ANBR01079 ANBR01078 ANBR01080 ANAQ00842 ANBR01053 ANBR01054 ANBQ01015 ANBQ01965 ANBQ01480 ANBQ01966 ANBQ01484 ANBS00304 ANBS00305 ANAR00675 ANAR05794 ANAR05793 ANBQ01751 ANBR00248 ANAS00596 ANAS00593 ANBQ01055 ANBQ01052 ANBQ01056 ANBQ01051 ANBQ01053 ANBQ01054 ANAQ01176 ANAQ01177 ANAR05091 ANAR05174 ANBQ00785 ANBQ00786 ANBR00256 ANBQ01664 ANBQ01259 ANBQ01258 APKS00537 APKS00538 ANAQ01781 ANBQ01041 ANBQ00109 ANBR02305 ANBR02304 ANBR02306 ANBR02307 ANAQ01376 ANAQ01377 ANAS00332 ANAS00331 ANAS01022 ANAS01024 ANAS01023 ANAS01019 ANAS01025 ANAS01016 ANAS01017 ANAS01020 ANAS01018 ANAS01021 ANAS01017 ANAS01022 ANAS01016 ANAS01018 ANAS01024 ANAS01019 ANAS01020 ANAS01021 ANAS01023 ANAS01025 ANBR00581 ANBR00580 ANAS00264 ANAP00948 ANAS00448 ANAR00952 ANAR00953 ANAR00955 ANAR00951 ANAR00954 ANAQ00470 ANAQ00510 ANAQ00511 ANAS00579 ANAQ00461 ANAQ00465 ANAQ00466 ANAQ00464 ANAQ00462 ANAQ00463 ANAQ00512 ANAQ00830 ANAQ00829 ANAQ00833 ANAQ00831 ANAQ00834 ANAQ00835 ANAQ00832 ANAQ01594 ANAR00232 ANAR00257 ANAR00254 ANAR00553 ANAR00558 ANAR05477 ANAR05476 ANAR05479 ANAR05478 ANAR05480 ANAR05481 ANAS00211 ANAS00628 ANBR00526 ANBR00609 ANBR00607 ANBR00604 ANBR00605 ANBR00608 ANBR00610 ANBR00606 ANBR01525 ANBR00666 APKS00356 ANAR00332 ANAR00331 ANBR00147 ANBR00142 ANBR00144 ANBR00145 ANBR00148 ANBR00150 ANBR00143 ANBR00149 ANBR00146 ANAS00569 ANAR00549 ANAR05005 ANAR05052 ANAR05053 ANAR05009 ANAR05054 ANAR05008 ANAR05004 ANAR05002 ANAR05006 ANAR05007 ANAR05003 ANBQ01248 ANBQ01247 ANBQ01245 ANBQ01244 ANBQ01246 ANBQ01412 ANBQ01409 ANBQ01408 ANBQ01410 ANBQ01411 ANBQ01413 ANAS00572 ANAS00574 ANAS00571 ANAS00575 ANAS00576 ANAQ01188 ANAR05265 ANAR05264 ANAR05610 ANAR05611 ANAS00204 ANAS00202 ANAS00203 ANAS00697 ANAS00698 ANAS00699…
FDA’s list runs to 68,342 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 Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA , MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED KINGDOM, VIETNAM, URUGUAY, and VENEZUELA.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out Delaware, Maine, New Mexico, Rhode Island and Vermont.
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 Sep 16, 2013.
- FDA classified it on Oct 15, 2013.
- FDA’s Enforcement Report published it on Oct 23, 2013.
- FDA terminated it on Oct 1, 2015.
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 68,342 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.