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U.S. Department of Health and Human Services

Class 1 Device Recall GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom

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 Class 1 Recall
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom
see related information
Date Posted October 15, 2013
Recall Status1 Open
Recall Number Z-0010-2014
Recall Event ID 66250
Premarket Notification
510(K) Numbers
K110213  K111116  K112722  K122445  K123125 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Code Information 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 5323856 - 2 5323856 - 3 5323856 - 4 5323856 - 5 5323856 - 6 5327897 - 1 5327897 - 2 ANAS00967 ANAS00968 ANAS00969 ANAS00970 ANAS00972 ANAS00973 ANAS00974 ANAS00975 ANAS00976 ANAS00977 ANAS00978 ANAS00979 ANAS00981 ANAS00982 ANAS00983 ANAS00984 ANAS00985 ANAS00997 ANAS00998 ANAS00906 ANAS00993 ANAS00909 5324418 - 1 5324418 - 2 5324418 - 3 5324492 - 1 5325318 - 1 5325318 - 2 ANAS00964 ANAS00965 5324012 - 1 5324012 - 2 5324012 - 3 5324672 - 1 ANAS00925 ANAS00926 ANAS00950 ANAS00951 ANAS00952 ANAS00953 ANAS00966 ANAS00971 ANAS00991 5326891 - 1 ANAS00800 ANAS00989 ANAS00990 5324604 - 1 5327482 - 1 5327482 - 2 5328933 - 1 ANAS00907 ANAS00934 ANAS01055 ANAS00276 ANAS00787 ANAS00933 ANAS00333 ANAS00386 ANAS01004 ANAS00994 ANAS00995 ANAS00996 ANAS00946 ANAS00947 ANAS00948 ANAS00949 ANAS00954 ANAS00955 ANAS00956 ANAS00957 ANAS00992 ANBS00603 ANBS00604 ANBS00800 ANBS00602 ANBS00370 70130790 - 1 70130790 - 2 70131952 - 1 70131952 - 2 70131952 - 3 70131952 - 4 70131952 - 5 70131952 - 6 70131952 - 7 70131952 - 8 70132184 - 1 70132184 - 2 70132184 - 3 70132184 - 4 70132184 - 5 70132537 - 1 70132537 - 1 70132537 - 2 70132537 - 2 70132537 - 3 70132619 - 1 70132619 - 2 70132619 - 3 70132619 - 4 70132619 - 5 70132619 - 6 70133381 - 1 70133381 - 2 70133381 - 3 70133381 - 4 70133381 - 5 70133381 - 6 70133381 - 7 70134330 - 1 70134330 - 2 70134330 - 3 ANBS00606 ANBS00687 ANBS00326 5321204 - 1 5321204 - 2 5321204 - 3 5322929 - 1 5322929 - 10 5322929 - 11 5322929 - 12 5322929 - 13 5322929 - 14 5322929 - 15 5322929 - 16 5322929 - 17 5322929 - 18 5322929 - 19 5322929 - 2 5322929 - 20 5322929 - 21 5322929 - 3 5322929 - 4 5322929 - 5 5322929 - 6 5322929 - 7 5322929 - 8 5322929 - 9 5324558 - 1 5326594 - 1 5326594 - 2 5328365 - 1 5328365 - 2 5328365 - 3 5328480 - 1 5328480 - 2 5329188 - 1 5329245 - 1 5329245 - 2 5329437 - 1 5329437 - 10 5329437 - 11 5329437 - 12 5329437 - 13 5329437 - 2 5329437 - 3 5329437 - 4 5329437 - 5 5329437 - 6 5329437 - 7 5329437 - 8 5329437 - 9 ANBS00748 ANBS00697 ANBS00698 ANBS00699 ANBS00780 ANBS00781 ANBS00782 ANBS00783 5325323 - 1 5325323 - 1 5325323 - 2 5325323 - 2 5328054 - 1 5328054 - 2 5328054 - 3 5328054 - 4 5328054 - 5 5328054 - 6 ANBS00754 ANBS00693 ANBS00694 ANBS00695 ANBS00696 ANBS00701 ANBS00702 ANBS00703 ANBS00704 ANBS00713 ANBS00714 ANBS00715 ANBS00716 ANBS00717 ANBS00718 ANBS00719 ANBS00720 ANBS00721 ANBS00761 ANBS00762 ANBS00798 5329715 - 1 5329651 - 1 ANBS00681 ANBS00686 ANBS00710 5329692 - 1 5329692 - 2 5329692 - 3 ANBS00755 ANBS00757 ANBS00758 ANBS00759 ANBS00733 ANBS00734 ANBS00735 ANBS00617 ANBS00770 ANBS00771 ANBS00779 ANBS00769 ANBS00737 ANBS00738 ANBS00739 ANBS00740 ANBS00741 ANBS00742 ANBS00743 ANBS00744 ANBS00745 ANBS00746 ANBS00672 ANBS00705 ANBS00706 ANBS00707 ANBS00708 ANBS00709 ANBS00722 ANBS00768 ANBS00801 ANBS00684 ANBS00685 ANBS00711 ANBS00712 ANBS00723 ANBS00724 ANBS00725 ANBS00726 ANBS00727 ANBS00728 ANBS00729 ANBS00730 ANBS00731 ANBS00732 ANBS00772 ANBS00773 ANBS00774 ANBS00775 ANBS00776 ANBS00777 ANBS00778 ANBS00784 ANBS00785 ANBS00786 ANBS00787 ANBS00788 ANBS00789 ANBS00790 ANBS00736 CBCS01139 CBCS01142 CBCS01143 CBCS01146 CBCS01147 CBCS01150 CBCS00975 CBCS00980 CBCS01215 CBCS01232 CBCS01174 5297602 - 1 5297658 - 1 5297658 - 2 5324971 - 1 5324971 - 10 5324971 - 2 5324971 - 3 5324971 - 4 5324971 - 5 5324971 - 6 5324971 - 7 5324971 - 8 5324971 - 9 CBCS00965 CBCS00968 CBCS00969 CBCS00970 CBCS00971 CBCS00972 CBCS00973 CBCS00974 CBCS00976 CBCS00977 CBCS00979 CBCS00981 CBCS00982 CBCS00983 CBCS01177 5326925 - 1 CBCS00963 CBCS01100 5324655 - 1 5324727 - 1 5325591 - 1 5325591 - 2 5325591 - 3 5326544 - 1 5326544 - 2 5326544 - 3 5326544 - 4 5326547 - 1 5326547 - 2 5326652 - 1 5326742 - 1 5326852 - 1 5326852 - 10 5326852 - 11 5326852 - 12 5326852 - 13 5326852 - 14 5326852 - 15 5326852 - 16 5326852 - 17 5326852 - 18 5326852 - 19 5326852 - 2 5326852 - 20 5326852 - 21 5326852 - 22 5326852 - 23 5326852 - 24 5326852 - 25 5326852 - 26 5326852 - 3 5326852 - 4 5326852 - 5 5326852 - 6 5326852 - 7 5326852 - 8 5326852 - 9 5326889 - 1 5326993 - 1 5326993 - 2 5327620 - 1 5327620 - 2 5327620 - 3 5327620 - 4 5327853 - 1 5327853 - 2 5327853 - 3 5328021 - 1 5328021 - 2 5328409 - 1 5328409 - 2 5328627 - 1 5328707 - 1 5328707 - 2 5328707 - 3 CBCS01026 CBCS01027 CBCS01028 CBCS01029 CBCS01030 CBCS01031 CBCS01032 CBCS01033 CBCS01034 CBCS01035 CBCS01036 CBCS01037 CBCS01038 CBCS01039 CBCS01040 CBCS01041 CBCS01042 CBCS01043 CBCS01044 CBCS01045 CBCS01046 CBCS01047 CBCS01048 CBCS01050 CBCS01052 CBCS01053 CBCS01054 CBCS01056 CBCS01057 CBCS01058 CBCS01062 CBCS01063 CBCS01064 CBCS01065 CBCS01066 CBCS01067 CBCS01068 CBCS01070 CBCS01071 CBCS01123 CBCS01124 CBCS01133 CBCS01136 CBCS01138 5323487 - 1 5324756 - 1 5324756 - 2 5325311 - 1 5326690 - 1 5326690 - 2 5326692 - 1 5326693 - 1 5326693 - 2 5326698 - 1 5326698 - 2 5326700 - 1 5320342 - 1 5320342 - 2 5320342 - 3 5320342 - 4 5320342 - 5 5325257 - 1 5325257 - 2 5325257 - 3 5325257 - 4 5325257 - 5 5325257 - 6 CBCS00964 CBCS00967 CBCS01181 CBCS01196 CBCS01197 CBCS01198 CBCS01199 CBCS01200 CBCS01201 CBCS01202 CBCS01203 CBCS01132 CBCS00957 CBCS00958 CBCS01089 CBCS01090 CBCS01148 CBCS01149 CBCS01151 CBCS01152 CBCS01153 CBCS01154 CBCS01155 CBCS01156 CBCS01157 CBCS01158 CBCS01160 CBCS01161 CBCS01162 CBCS01163 CBCS01164 CBCS01168 CBCS01135 CBCS01165 CBCS01166 CBCS01167 CBCS01169 CBCS01091 CBCS01092 CBCS01093 CBCS01094 CBCS01095 CBCS01096 CBCS01097 CBCS01098 CBCS01099 5329011 - 1 CBCS00953 CBCS00955 CBCS00959 CBCS00960 CBCS00961 CBCS00962 CBCS00966 CBCS00984 CBCS00985 CBCS01055 CBCS01059 CBCS01073 CBCS01074 CBCS01075 CBCS01076 CBCS01077 CBCS01078 CBCS01103 CBCS01109 CBCS01110 CBCS01111 CBCS01112 CBCS01113 CBCS01114 CBCS01115 CBCS01116 CBCS01117 CBCS01118 CBCS01119 CBCS01120 CBCS01125 CBCS01126 CBCS01127 CBCS01129 CBCS01130 CBCS01233 CBCS01236 CBCS01252 CBCS01253 CBCS01254 CBCS01069 CBCS01101 CBCS01102 CBCS01121 CBCS01122 5327572 - 1 CBCS01061 5325609 - 1 5325609 - 2 5325609 - 3 CBCS01049 CBCS01051 CBCS01060 CBCS01084 CBCS01104 CBCS01105 CBCS01106 CBCS01107 CBCS01108 5326361 - 1 5326361 - 2
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
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 Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees were sent on 8/28/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 28, 2013. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manger and director of Biomedical / clinical engineering. The letter described the Safety Issue, Safely Instructions, Affected Product Details, Product Correction and Contact Information (1-800-345-2700 US).
Quantity in Commerce 911 (252 US, 659 OUS)
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA
510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.
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