GE Healthcare, Aisys CS2,1011-9050-000
Medical device recall Z-0681-2016. Published in FDA’s Enforcement Report on Jan 27, 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 Jan 27, 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 1 state named
- 2627 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?
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
2627, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU01785 APWU01827 APWU01988 APWU01989 APWU01990 APWU01991 APWU01992 APWU01993 APWU01994 APWU01995 APWU01996 APWU01997 APWU01576 APWU01577 APWU01578 APWU00707 APWU00708 APWU00709 APWU00710…
Every code shown here, 2,000 characters
APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU01785 APWU01827 APWU01988 APWU01989 APWU01990 APWU01991 APWU01992 APWU01993 APWU01994 APWU01995 APWU01996 APWU01997 APWU01576 APWU01577 APWU01578 APWU00707 APWU00708 APWU00709 APWU00710 APWU00711 APWU00712 APWU00713 APWU01486 APWU01487 APWU01488 APWU01489 APWU01490 APWU01491 APWU01492 APWU01493 APWU01494 APWU01495 APWU01825 APWU01909 APWU02017 APWU02018 APWU02019 APWU02020 APWU01054 APWU01055 APWU01056 APWU00840 APWU00841 APWU00842 APWU00843 APWU00844 APWU00845 APWU00846 APWU00847 APWU01608 APWU01609 APWU01610 APWU01611 APWU01612 APWU01613 APWU01614 APWU01615 APWU02066 APWU02067 APWU00728 APWU00729 APWU00730 APWU00751 APWU00752 APWU00753 APWU00754 APWU00755 APWU01595 APWU01240 APWU01241 APWU01242 APWU01243 APWU01244 APWU01359 APWU01949 APWU01410 APWU01411 APWU01412 APWU00767 APWU00768 APWU00769 APWU01131 APWU01132 APWU01133 APWU01340 APWU01341 APWU01342 APWU01343 APWU01344 APWU01616 APWU01617 APWU01618 APWU01619 APWU01620 APWU01621 APWU01622 APWU01623 APWU01699 APWU01700 APWU01701 APWU01702 APWU01703 APWU01704 APWU01705 APWU01706 APWU01707 APWU01708 APWU01709 APWU01710 APWU01652 APWU01653 APWU01654 APWU01655 APWU01897 APWU01096 APWU01097 APWU01098 APWU01099 APWU01100 APWU01101 APWU01102 APWU01103 APWU01104 APWU01105 APWU01106 APWU01107 APWU01108 APWU01109 APWU01496 APWU01497 APWU01498 APWU01499 APWU01500 APWU01501 APWU01502 APWU01503 APWU01504 APWU01505 APWU01736 APWU01737 APWU01579 APWU01580 APWU01581 APWU01582 APWU00864 APWU00865 APWU00866 APWU00867 APWU00868 APWU00869 APWU00870 APWU00871 APWU01149 APWU01150 APWU01910 APWU00913 APWU01265 APWU01266 APWU01911 APWU01912 APWU01913 APWU01914 APWU01922 APWU01923 APWU01929 APWU01930 APWU01931 APWU01932 APWU01933 APWU01934 APWU01935 APWU01936 APWU01937 APWU01938 APWU01422 APWU00764 APWU00765 APWU00766 APWU00889 APWU02061 APWU01443 APWU01444 APWU01445 APWU01446 APWU01447 APWU01448 APWU01449 APWU01450 APWU01451 APWU01452 APWU01774 APWU01775 APWU01095 APWU00725 APWU00726…
FDA’s list runs to 26,287 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 - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
The states and territories these words name
- Puerto Rico
They leave out New Hampshire, Vermont and Wyoming.
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 Dec 15, 2015.
- FDA classified it on Jan 21, 2016.
- FDA’s Enforcement Report published it on Jan 27, 2016.
- FDA terminated it on Sep 21, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, 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 26,287 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.