GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom
Medical device recall Z-0010-2014. 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 25 states named
- 911 (252 US, 659 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 unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
911 (252 US, 659 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 # APHS00701 APHS00802 APHS00729 APHS00730 APHS00700 APHS00692 APHS00932 APHS00886 APHS00861 APHS00865 APHS00866 APHS00867 APHS00868 APHS00887 APHS00888 APHS00860 APHS00881 70138420 - 1 APHS00844 APHS00711 APHS00712…
Every code shown here, 1,997 characters
Mfg Lot or Serial # APHS00701 APHS00802 APHS00729 APHS00730 APHS00700 APHS00692 APHS00932 APHS00886 APHS00861 APHS00865 APHS00866 APHS00867 APHS00868 APHS00887 APHS00888 APHS00860 APHS00881 70138420 - 1 APHS00844 APHS00711 APHS00712 5324664 - 1 APHS00703 APHS00704 5328496 - 1 APHS00690 APHS00719 APHS00720 APHS00722 APHS00723 APHS00828 APHS00834 APHS00835 APHS00836 APHS00843 APHS00809 APHS00854 APHS00855 APHS00856 APHS00857 APHS00858 APHS00691 APHS00702 APHS00705 APHS00721 APHS00807 APHS00808 APHS00811 APHS00685 APHS00695 APHS00696 APHS00697 APHS00698 APHS00699 APHS00805 APHS00806 APHS00812 APHS00810 APHS00864 APHS00643 APHS00644 APHS00645 APHS00646 APHS00647 APHS00648 APHS00649 APHS00650 APHS00651 APHS00652 APHS00653 APHS00654 APHS00655 APHS00656 APHS00657 APHS00666 APHS00667 APHS00731 APHS00732 APHS00733 APHS00734 APHS00735 APHS00736 APHS00737 APHS00738 APHS00739 APHS00740 APHS00741 APHS00742 APHS00743 APHS00744 APHS00745 APHS00748 APHS00749 APHS00750 APHS00751 APHS00752 APHS00753 APHS00754 APHS00755 APHS00756 APHS00757 APHS00758 APHS00759 APHS00760 APHS00761 APHS00762 APHS00763 APHS00764 APHS00765 APHS00766 APHS00767 APHS00768 APHS00769 APHS00770 APHS00771 APHS00772 APHS00773 APHS00774 APHS00775 APHS00776 APHS00777 APHS00778 APHS00779 APHS00780 APHS00781 APHS00782 APHS00783 APHS00784 APHS00785 APHS00786 APHS00787 APHS00788 APHS00789 APHS00790 APHS00933 APHS00686 APHS00687 APHS00688 APHS00689 APHS00706 APHS00707 APHS00710 APHS00726 APHS00826 APHS00827 APHS00838 APHS00846 APHS00847 APHS00869 APHS00871 APHS00874 APHS00875 APHS00876 APHS00882 APHS00883 APHS00884 APHS00885 APHS00872 APHS00873 APHS00693 APHS00725 APHS00801 APHS00879 APHS00880 APHS00727 APHS00728 APHS00682 APHS00877 APHS00878 APHS00849 APHS00850 APHS00852 APHS00853 APHS00839 APHS00840 APHS00841 APHS00842 APHS00677 APHS00859 APHS00253 APHS00694 APHS00804 APHS00845 APHS00862 APHS00863 ANAS01058 ANAS01059 ANAS00814 ANAS00265 ANAS01006 ANAS01007 ANAS01009 ANAS01010 ANAS01011 ANAS01012 ANAS01013 ANAS01014…
FDA’s list runs to 9,684 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 the states of US: AK, AZ, CA, CO, DE, FL, GA, IL, KY, LA, MD, MI, MN, MS, MT, NV, NY, NC, OH, OR, PA, SC, TX, WY, and WI and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COST ARICA, CROATIA, CZECH REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KAZAHHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LITHUANIA, MAURITITUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPINES, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, and VENEZUELA.
The states and territories these words name
25 states and territories.
Every one of them
- Alaska
- Arizona
- California
- Colorado
- Delaware
- Florida
- Georgia
- Illinois
- Kentucky
- Louisiana
- Maryland
- Michigan
- Minnesota
- Mississippi
- Montana
- North Carolina
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- Texas
- Wisconsin
- 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 Aug 28, 2013.
- FDA classified it on Oct 15, 2013.
- FDA’s Enforcement Report published it on Oct 23, 2013.
- FDA terminated it on Jan 30, 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 9,684 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.