GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000
Medical device recall Z-0677-2016. 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
- 1081 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, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.
1081, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
AESPIRE 7900 ANCU00662 ANCU00813 ANCU00814 ANCU00815 ANCU00816 ANCU00817 ANCU00818 ANCU00597 ANCU00598 ANCU00599 ANCU00600 ANCU00601 ANCU00671 ANCU00672 ANCU00673 ANCU00676 ANCU00678 ANCU00683 ANCU00830 ANCU00832 ANCU00870 ANCU00871…
Every code shown here, 1,993 characters
AESPIRE 7900 ANCU00662 ANCU00813 ANCU00814 ANCU00815 ANCU00816 ANCU00817 ANCU00818 ANCU00597 ANCU00598 ANCU00599 ANCU00600 ANCU00601 ANCU00671 ANCU00672 ANCU00673 ANCU00676 ANCU00678 ANCU00683 ANCU00830 ANCU00832 ANCU00870 ANCU00871 ANCU00872 ANCU00873 ANCU00874 ANCU00875 ANCU00629 ANCU00630 ANCU00638 ANCU00639 ANCU00640 ANCU00641 ANCU00806 ANCU00604 ANCU00684 ANCU00836 ANCU00837 ANCU00839 ANCU00786 ANCU00680 ANCU00681 ANCU00625 ANCU00626 ANCU00677 ANCU00618 ANCU00619 ANCU00620 ANCU00602 ANCU00603 ANCU00448 ANCU00449 ANCU00770 ANCU00771 ANCU00865 ANCU00866 ANCU00867 ANCU00803 ANCU00605 ANCU00663 ANCU00682 ANCU00685 ANCU00458 ANCU00459 ANCU00831 ANCU00653 ANCU00820 ANCU00591 ANCU00592 ANCU00586 ANCU00583 ANCU00584 ANCU00585 ANCU00825 ANCU00593 ANCU00664 ANCU00838 ANCU00433 ANCU00679 ANCU00555 ANCU00456 ANCU00457 ANCU00590 ANCU00661 ANCU00669 ANCU00670 ANCU00674 ANCU00819 ANCU00807 ANCU00808 ANCU00809 ANCU00810 ANCU00811 ANCU00812 ANCU00588 ANCU00589 ANCU00455 ANCU00587 ANCU00868 ANCU00581 ANCU00582 ANCU00466 ANCU00467 ANCU00468 ANCU00469 ANCU00840 ANCU00434 ANCU00435 ANCU00436 ANCU00437 ANCU00438 ANCU00439 ANCU00440 ANCU00822 ANCU00823 ANCU00824 ANCU00827 ANCU00828 ANCU00654 ANCU00729 ANCU00730 ANCU00496 ANCU00675 ANCU00624 ANCU00826 ANCU00829 ANCU00465 ANCU00441 ANCU00844 ANCU00656 ANCU00876 ANCU00877 ANCU00878 ANCU00426 ANCU00427 ANCU00485 ANCU00470 ANCU00608 ANCU00609 ANCU00610 ANCU00611 ANCU00612 ANCU00613 ANCU00789 ANCU00617 ANCU00445 ANCU00446 ANCU00490 ANCU00491 ANCU00492 ANCU00493 ANCU00494 ANCU00495 ANCU00497 ANCU00498 ANCU00518 ANCU00519 ANCU00521 ANCU00522 ANCU00665 ANCU00666 ANCU00709 ANCU00710 ANCU00711 ANCU00772 ANCU00773 ANCU00845 ANCU00846 ANCU00687 ANCU00688 ANCU00737 ANCU00738 ANCU00859 ANCU00860 ANCU00861 ANCU00693 ANCU00694 ANCU00695 ANCU00851 ANCU00852 ANCU00853 ANCU00854 ANCU00855 ANCU00856 ANCU00857 ANCU00858 ANCU00500 ANCU00501 ANCU00505 ANCU00506 ANCU00507 ANCU00508 ANCU00509 ANCU00510 ANCU00511 ANCU00516 ANCU00517 ANCU00696 ANCU00697…
FDA’s list runs to 10,835 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 10,835 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.