FDAFDA · Food and drugs·Recall number Z-0010-2014
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Published October 23, 2013 · Recall initiated: August 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- 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 ANAS01015 ANAS01026 ANAS01027 ANAS01028 ANAS01029 ANAS01030 ANAS01031 ANAS01032 ANAS01033 ANAS01034 ANAS01035 ANAS01036 ANAS01037 ANAS01038 ANAS01039 ANAS01040 ANAS01041 ANAS01042 ANAS01043 ANAS01045 ANAS01046 ANAS01047 ANAS01048 ANAS01049 ANAS01050 ANAS01051 ANAS01052 ANAS00536 ANAS01001 ANAS01002 ANAS01005 ANAS00475 ANAS00821 ANAS01067 ANAS01068 ANAS01069 ANAS01070 ANAS01071 ANAS00999 ANAS01000 ANAS00788 ANAS00789 ANAS00790 ANAS00793 ANAS00794 ANAS00795 ANAS00796 ANAS00797 ANAS00798 ANAS00799 ANAS00913 ANAS00914 ANAS00915 5323093 - 1 5324910 - 1 5324910 - 2 5324910 - 3 5324910 - 4 5324910 - 5 5324911 - 1 5325677 - 1 5325677 - 10 5325677 - 11 5325677 - 12 5325677 - 13 5325677 - 14 5325677 - 15 5325677 - 16 5325677 - 17 5325677 - 2 5325677 - 3 5325677 - 4 5325677 - 5 5325677 - 6 5325677 - 7 5325677 - 8 5325677 - 9 5326146 - 1 5326146 - 2 5326146 - 3 5326146 - 4 5326146 - 5 5326146 - 6 5326146 - 7 5326146 - 8 5327169 - 1 5327169 - 2 5327169 - 3 5327169 - 4 5327169 - 5 5327169 - 6 5327288 - 1 5327288 - 2 5327288 - 3 5329262 - 1 5329262 - 10 5329262 - 11 5329262 - 12 5329262 - 13 5329262 - 14 5329262 - 15 5329262 - 16 5329262 - 17 5329262 - 18 5329262 - 19 5329262 - 2 5329262 - 3 5329262 - 4 5329262 - 5 5329262 - 6 5329262 - 7 5329262 - 8 5329262 - 9 ANAS01053 ANAS01054 5325959 - 1 5325959 - 10 5325959 - 11 5325959 - 12 5325959 - 13 5325959 - 2 5325959 - 3 5325959 - 4 5325959 - 5 5325959 - 6 5325959 - 7 5325959 - 8 5325959 - 9 5326782 - 1 5326782 - 2 ANAS00922 ANAS00932 ANAS00923 ANAS00924 ANAS00900 ANAS00905 ANAS00935 ANAS00936 ANAS00937 ANAS00938 ANAS00939 ANAS00940 ANAS00941 ANAS00942 ANAS00943 ANAS00944 ANAS00945 5323856 - 1 532
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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