{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Waukesha", "address_1": "3000 N Grandview Blvd", "reason_for_recall": "GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correc", "address_2": "", "product_quantity": "1458 (336 US, 1122 OUS)", "code_info": "Mfg Lot or Serial # 00000270627GE3 00000334603GE8 00000323252GE7 00000315108GE1 00000291160GE0 00000218194GE9 00000334300GE1 00000253041GE8 00000256043GE1 00000L3A331FA4 00000289595GE1 00000323665GE0 00000323664GE3 00000275711GE0 00000293133GE5 00000256042GE3 00000175340GE9 00000335983GE3 00000275712GE8 00000275709GE4 00000323672GE6 00000323671GE8 00000226324GE2 00000208598GE3 00000187433GE8 00000187429GE6 00000226323GE4 00000304907GE9 00000327610GE2 00000303033GE5 00000308064GE5 00000318457GE9 00000306536GE4 00000304924GE4 00000LA70CA012 00000187434GE6 00000321124GE0 00000321123GE2 00000222541GE5 00000284793GE7 00000298539GE8 00000171505GE1 00000304914GE5 00000304910GE3 00000303035GE0 00000303034GE3 00000229351GE2 00000315104GE0 00000327604GE5 00000337320GE6 00000280422GE7 00000L0372A1AE 00000275708GE6 00000270631GE5 00000260247GE2 00000224182GE6 00000207773GE3 00000334305GE0 00000334304GE3 00000334303GE5 00000332778GE0 00000330087GE8 00000293134GE3 00000224186GE7 00000300999GE0 00000304909GE5 00000304908GE7 00000321116GE6 00000323673GE4 00000287149GE9 00000287148GE1 00000L3A58A61D 00000172803GE9 00000311101GE0 00000301003GE0 00000L02408868 00000L3A868449 00000291164GE2 00000235878GE6 00000169498GE3 00000256046GE4 00000172679GE3 00000218121GE2 00000LB8CDAE78 00000L0235EBD6 00000222542GE3 00000172802GE1 00000311102GE8 00000226326GE7 00000226325GE9 00000330086GE0 00000332779GE8 00000266124GE7 00000L0235EBD7 00000175338GE3 00000235877GE8 00000L0270044E 00000334299GE5 00000334298GE7 00000334297GE9 00000323668GE4 00000323667GE6 00000323666GE8 00000306541GE4 00000306540GE6 00000306539GE8 00000306538GE0 00000306537GE2 00000334604GE6 00000298541GE4 00000298540GE6 00000308058GE7 00000308060GE3 00000308059GE5 00000298536GE4 00000171126GE6 00000L3A868442 00000241475GE3 00000171115GE9 00000332783GE0 00000321115GE8 00000320717GE2 00000320716GE4 00000320715GE6 00000320714GE9 00000298533GE1 00000296984GE8 00000296983GE0 00000296982GE2 00000296981GE4 00000171114GE2 00000222538GE1 00000268434GE8 00000256045GE6 00000300998GE2 00000300997GE4 00000300996GE6 00000298542GE2 00000251408GE1 00000247372GE6 00000247371GE8 00000247370GE0 00000171942GE6 00000339695GE9 00000339694GE2 00000339693GE4 00000339692GE6 00000332787GE1 00000332786GE3 00000332785GE5 00000332784GE8 00000327609GE4 00000327608GE6 00000287045GE9 00000287044GE2 00000323669GE2 00000278636GE6 00000260248GE0 00000229375GE1 00000229377GE7 00000229376GE9 00000171641GE4 00000171117GE5 00000171116GE7 00000315101GE6 00000312652GE1 00000312651GE3 00000312650GE5 00000312649GE7 00000294225GE8 00000294220GE9 00000294219GE1 00000294218GE3 00000293138GE4 00000262815GE4 00000175341GE7 00000L3A331E5D 00000328872GE7 00000L0235EF79 00000194706GE8 00000266125GE4 00000315105GE7 00000312648GE9 00000306542GE2 00000253042GE6 00000L3A254331 00000218195GE6 00000321117GE4 00000334596GE4 00000294222GE5 00000294221GE7 00000171118GE3 00000270630GE7 00000311099GE6 00000311098GE8 00000334308GE4 00000334307GE6 00000334306GE8 00000327601GE1 00000262813GE9 00000L026B2276 00000208599GE1 00000207770GE9 00000268435GE5 00000260246GE4 00000233075GE1 00000222537GE3 00000298537GE2 00000171128GE2 00000L021DFE1D 00000306828GE5 00000294223GE3 00000327603GE7 00000327602GE9 00000296980GE6 00000175339GE1 00000175337GE5 00000224183GE4 00000253648GE0 00000251409GE9 00000270629GE9 00000L3AA73A34 00000207771GE7 00000L3A331A81 00000330084GE5 00000308063GE7 00000308062GE9 00000180600GE9 00000208597GE5 00000L0219C8D1 00000171119GE1 00000340255GE9 00000337318GE0 00000241476GE1 00000235881GE0 00000T13077003 00000224184GE2 00000171506GE9 00000L3A3D0C02 00000172678GE5 00000235879GE4 00000L02167F58 00000260243GE1 00000218122GE0 00000334595GE6 00000334312GE6 00000334311GE8 00000L3A3D0C2D 00000171941GE8 00000275710GE2 00000278632GE5 00000247368GE4 00000L026D1B92 00000L026D1C4C 0000AJ12082002 00000284797GE8 00000180601GE7 00000334600GE4 00000334599GE8 00000278633GE3 00000340261GE7 00000340260GE9 00000340259GE1 00000340258GE3 00000340257GE5 00000340256GE7 00000339696GE7 00000N11330001 00000A12174006 00000304919GE4 00000304918GE6 00000304917GE8 00000304916GE0 00000304915GE2 00000304913GE7 00000304912GE9 00000304911GE1 00000304906GE1 00000304905GE3 00000303037GE6 00000303036GE8 00000241474GE6 00000241473GE8 00000233074GE4 00000233073GE6 00000233072GE8 00000229380GE1 00000294227GE4 00000291163GE4 00000291162GE6 00000291161GE8 00000337319GE8 00000330083GE7 00000330082GE9 00000330081GE1 00000301000GE6 00000LFB4430A0 00000287043GE4 00000287042GE6 00000286722GE4 00000286721GE6 00000286720GE8 00000286719GE0 00000284798GE6 00000218123GE8 00000207772GE5 00000171129GE0 00000L06AD4DD2 00000322629GE7 00000315106GE5 00000194705GE0 00000226322GE6 00000280421GE9 00000280420GE1 00000266123GE9 00000315107GE3 00000212000GE4 00000251410GE7 00000247367GE6 00000241477GE9 00000171944GE2 00000287047GE5 00000253045GE9 00000253044GE2 00000311097GE0 00000L3A868437 00000298534GE9 00000306832GE7 00000304923GE6 00000322628GE9 00000306829GE3 00000287046GE7 00000L3A3D0C91 00000L3A3D0BFC 00000L026D1E78 00000F12320015 00000F12320012 00000F12320008 00000L02127C27 00000303031GE9 00000LA714FCD7 00000LA714FCCF 00000N13064004 00000H13021001 00000D12363003 00000J11258003 00000J11258001 0000AB12083002 00000N11159007 00000L10106002 00000L3A55FA1E 00000L3A8FD1FD 00000N11111001 00000G11103001 00000E12332008 000AA112343001 0000AA11243001 00000V10334001 00000E12332001 00000P12335002 00000N10127001 00000D11255003 00000B11131010 00000W13204010 00000T12334012 00000Q13022002 00000L13134004 00000L13134001 000000Z9309005 000000Z9309002 00000D11314001 0000AC12279003 0000AC12279001 00000P11312017 0000AF13080002 000000G9337002 00000L3A2D138C 0000AZ12143001 0000AL12142005 0000AC12130003 00000S11222004 00000S11222001 00000L3A5FEACE 00000L3A5F3D0A 00000L3A5F3D05 00000L3A5F3C57 00000H11083001 00000W11101004 00000L3A2BAB50 00000L3A2BABE7 00000L3A2BABF4 0000AH12080002 00000L3A2BABE8 00000H12059002 000000G9337003 00000L026875C5 0000AL12142012 0000AL12142010 0000AL12142007 0000AC12130005 00000Y10245001 00000K10130001 00000H10153002 00000H10153001 00000F10090001 0000AV12283004 00000LA70A45FA 00000P12242001 00000A12174019 00000W10230002 00000N13064006 00000N13064003 00000N13064002 00000N11105002 00000M13123003 00000M13065001 00000M10162001 00000G10161002 000000G9337001 00000L3AB4D7EE 00000180602GE5 00000L3A54DE13 00000260242GE3 00000256047GE2 00000293135GE0 00000L3A2BABD0 00000N13093003 00000N13093002 0000AL12233004 00000A12174001 00000L3AB2DCF5 0000AN11298008 00000180598GE5 00000LA707B9AA 00000253043GE4 00000L3AB4D867 00000L3A6AB685 00000284790GE3 00000283267GE3 00000280419GE3 00000278635GE8 00000278634GE1 00000171943GE4 00000L3A25444E 00000301001GE4 00000289587GE8 00000251413GE1 00000251412GE3 000S519685AW14 00000187436GE1 00000187435GE3 00000311087GE1 00000194702GE7 00000193593GE1 00000193592GE3 00000L6B045EFC 00000268433GE0 00000289592GE8 00000289591GE0 00000289589GE4 00000298535GE6 00000289588GE6 00000L022EE84E 00000LA7142C7C 00000LA713783D 00000LA712A01B 00000330080GE3 00000284796GE0 00000270628GE1 00000308067GE8 00000171644GE8 00000289593GE6 00000268437GE1 00000268436GE3 00000287154GE9 00000287153GE1 00000327607GE8 00000327606GE0 00000327605GE2 00000330079GE5 00000330078GE7 00000251411GE5 00000T10291001 00000G10307002 00000X11354004 00000M11265002 00000J11258002 00000D11255001 00000C11269001 00000W13115013 00000R11202006 00000R11202005 00000R11202004 0000AH13150006 00000P13137004 00000R12086004 00000H11056001 00000V10245002 00000D10252001 00000L10351002 00000C10363001 00000U11174002 00000U11174001 00000L10351003 00000S11287002 00000S11287001 00000V10245006 00000N11172001 00000S11222002 00000T12333001 00000S11222006 00000N13163002 00000L13122001 00000V10245001 00000T12334008 00000T12334005 00000X11354003 00000R13025002 00000P11146002 00000R10250001 00000M13123010 00000M13123009 00000M13123008 00000M13123007 00000S11222005 00000S11222003 0000AB10235006 00000N11028004 00000N11159008 00000N11159002 00000R11166005 00000R11166001 00000N11159006 00000H11147006 00000N12146004 00000N12146003 00000T13081001 0000AE11203001 00000R11027002 00000K13008003 00000K13008001 0000AB10235002 00000W11112005 00000R11166003 00000R11166002 0000AJ12167002 0000AG12165002 00000M13046004 00000S12349001 00000P13042002 00000L13171001 00000F12030004 00000F12030001 00000P11312011 00000P11312006 00000R13017001 00000K12097001 0000AF12258001 00000Z12251002 00000P12242005 0000AB10235003 00000N10260002 00000T12032010 00000Q12067001 00000V10245003 00000T10291002 00000N10260001 00000G10307001 00000L3A9C89CE 0000AL12144006 0000AL12144003 00000N12146012 00000N12146005 00000W10349002 00000M11265005 00000M11265003 00000X11354002 00000V11083001 0000AE11234001 0000AA11243003 00000R11202002 00000R11202001 00000Q11173004 00000Q11173003 00000G11175002 00000X13107002 00000W13115003 00000P13087002 00000G13078001 00000Z12158001 00000M12157004 00000M12157003 00000Z12166003 0000AC13154001 0000AA11243002 00000C12070001 0000AF13080001 00000G13078004 0000AC13154002 00000W11328005 00000W11328007 0000AD12125006 0000AC12130004 S082421120267A 0S082421120267 00000L3A4817AE 00000W10125001 00000R11042001 00000M11045002 00000L10351006 00000L13023001 00000N11105001 00000L3A620C24 00000W12346001 00000W11328006 00000W11328004 00000N12146002 0000AB12083003 00000Z12093002 00000Z12093001 00000R12086009 00000W13115007 00000P13170002 00000B11095001 00000P11312016 00000M13046002 00000Y11250001 00000Y12340002 00000T13077001 0000AM12303002 00000B12305002 00000W11328009 00000T12338001 00000P11312001 00000M13123001 00000T13073005 0000AC12254001 00000I13066001 00000H13039001 00000T12334003 00000R13018002 00000R10250002 00000V10245007 00000D10252002 00000X10350004 00000W10349001 00000L3A443C8F 00000L3A443C82 00000N12348003 00000N12348002 00000N12348001 00000V10245004 00000E10265003 00000E10265002 0000ZA10223001 00000E10265001 0000AG10264001 00000V10245008 00000L10277001 00000J13127002 0000AM11355001 00000X11354001 00000N11330002 00000B11131009 00000Y12317001 00000N13014002 00000L13134010 00000L13134002 00000W11054003 00000J13063001 00000LA713461D 00000M13123006 0000AD12269001 00000S12271001 00000N13014001 00000L13011001 00000X12244002 00000W11101002 00000W11101001 00000J11077003 00000P12242002 00000N12348007 00000U13043002 00000U13043001 00000P13042001 00000N11102001 00000B11131007 00000B11131002 0000AC13154003 0000AE12247001 0000AB10235005 00000T12334007 00000T12334006 00000T12334004 00000T12334002 00000M13065002 00000U13185001 00000S13156002 00000S13156001 00000Z12158002 00000N12146009 00000N12146008 00000L3A9C88B6 00000Q11173002 00000B11131006 0000AF13149001 00000Z12251003 00000X12255002 00000S11020003 00000J11024001 00000P13087001 00000N13093001 0000AM11355002 00000R11353001 00000L3AA5ADDB 0000AZ12227001 00000X12255003 00000Z12251004 000000G9337004 00000Y12172003 00000Y12172002 00000Y12172001 00000F12320005 00000F12320002 00000B11131001 0000AM12222001 0000AA12221002 0000AA12221001 00000F12320010 0000AM12303007 0000AM12303006 00000F12320009 00000F12320007 00000E10011005 00000E10011004 00000E10011002 00000E10011001 00000S12328003 00000S12328002 00000S12328001 00000F12320006 00000F12320004 0000AE11294001 00000T12032004 00000S11019010 00000S11019009 00000S11019002 00000R11020005 00000Q11060006 00000H11027003 00000H11027002 00000H11027001 00000E10336009 00000E10336007 00000E10336006 00000E10336005 0000ZA12156001 00000Y12172004 00000E12332016 00000E12332015 00000E12332014 00000E12332012 00000E12332011 00000E12332002 00000Z11074002 0000AK12313002 0000AK12313001 0000AB10126002 00000T10123004 00000T10123002 00000T10123001 00000H10028003 00000LE23E65BE 00000L3A3C7CDB 0000AS12310002 00000F10229002 00000F10229001 000000G9337012 0000AS12310001 00000X12255001 00000L3A6CE9F2 00000M10189003 00000M10189002 00000J10208004 00000J10208001 00000L3A2AE16C 00000L3A330990 0000AL12142002 0000AG12137002 0000AG12137001 00000Z11074001 00000V11073004 00000V11073003 00000S13183004 00000S13183003 00000S13183002 00000S11020005 00000R12115002 00000R12115001 00000N11111002 00000N11105004 00000L12114001 00000L11098001 00000J13127001 00000J11077005 00000B11131011 00000B11131005 000000G9337017 0000AC12277002 00000W11101003 00000R11031002 00000R11027001 00000ZA9324001 00000U10061001 00000T10071001 00000M10075002 00000M10075001 00000LA8CEAF88 000000G9337020 0000AB11266003 0000AB11266002 0000AB11266001 00000K11179002 00000K11179001 0000AD12125008 0000AD12125007 0000AD12125005 00000T11061002 000000L9343005 00000K11117001 00000H11147005 00000H11147004 00000H11147001 00000M12157001 00000L13134009 00000L13134007 00000L13134006 00000S11020002 00000R11020006 00000R11020004 00000R11020003 00000J11024005 00000J11024004 00000J11024003 00000J11024002 00000P11278001 00000K11259005 00000K11259004 00000C10256003 00000C10256002 00000C10256001 00000L3A6CEB46 00000S13183001 0000AB10126004 0000AB10126003 00000N10127003 00000M10225001 00000J10208002 00000A10194005 00000J10215003 00000J10215002 00000L3A2544FB 00000L02546F3B 00000Z13168004 00000LA715C6B3 00000X11362002 00000J12026001 00000J12025011 00000J12025010 00000J12025009 00000J12025003 00000J12025002 0000AV12283003 0000AQ12290002 0000AL12296003 0000AL12296002 0000AL12296001 0000AC12279002 00000N12033007 00000T11061004 00000M10146001 000000G9337013 000000G9337015 00000N10337010 00000N10337009 00000N10337008 00000Z12166004 00000N10337001 00000M12157005 00000J12025006 00000J12025005 00000J12025004 00000J12025001 000000L9343004 00000W13115012 00000W13115010 00000W13115009 00000W13115008 00000W13115006 00000W13115005 00000W13115004 00000W13115002 00000W13115001 00000K13120002 00000K13120001 00000J13079001 00000U10259002 00000U10258003 00000U10258002 00000L10286003 00000T12032009 00000T12032008 00000T12032007 00000T12032003 00000T12032002 00000T12032001 00000A12174010 00000A12174008 00000L3A51377D 000000G9337007 0000AX12262007 00000S11019008 00000S11019007 00000S11019005 00000S11019004 00000S11019003 00000N10337017 00000N10337016 00000N10337015 00000N10337006 00000N10337005 00000E10336002 00000E10336001 0000AM12222005 00000A12174004 00000L3A6CEAFD 00000L3A6CD7DE 00000L3A6CD7CC 00000L3A6CEB06 00000L0247DC13 00000L0246DCE9 000000G9337016 00000L3A25474B 0000AD12202003 0000AD12202002 0000AD12202001 00000LFB4CD024 0000AD12125002 000SX976365012 00000L020E0B44 00000L3AAFB1B5 00000J10215001 00000LA7072149 00000LA8CE7F5A 00000K12215002 00000K12215001 00000U12263004 0000AK12313003 00000H10131002 0000AB12018003 00000P11059001 00000K13008002 0000AE11234002 00000P11235001 00000B12305001 00000Q13094001 00000N13163004 0000AN11298007 000000G9337018 00000G10161001 00000278637GE4 00000L026876FF 000000Z9356001 00000T10109001 00000L10106001 00000H10028002 00000L143CFC99 00000P12335001 00000LA7047CBA 00000Y12317003 0000AL12144009 00000M11045001 000000Z9309003 00000Z12166001 00000S11049001 00000W10250001 00000L3A3C7DEF 0000AX12262006 0000AX12262002 0000AX12262001 00000N11159005 00000N11159004 00000U13158002 00000U13158001 000000M9322001 00000W13204003 00000W13204001 00000T13077004 00000T12338002 00000N10337007 0000AD10244001 00000F12030005 0000AC12279006 00000U11174003 0000AM12159001 00000U12104001 0000AC12130001 000000G9337009 00000A10194001 00000T11124001 00000N11125001 000000G9337010 0000AV12283001 0000AM12303005 0000AC12279005 00000U12263001 00000N11159003 00000E12332013 00000U10259001 00000T10294001 00000J10293001 00000R10105001 00000R12086006 0000AC13154005 00000R11166004 00000Q11152003 00000Q11152002 00000L11150001 00000H11147007 00000H11147003 00000H11147002 00000F11151001 00000J10113001 00000U11189001 00000E12332005 00000J13032003 00000J13032001 0000AH13150002 00000P13170001 00000S11020008 00000S11020007 00000S11020006 00000N11019001 00000P11312013 0000AC13154004 0000AE11234003 00000Q11048001 000000L9343008 00000G11175001 00000W12046002 00000W12046001 00000W11328008 00000T12334010 00000T12334009 00000S11081003 00000P11312010 00000W11328001 00000M11265004 00000H10028001 00000W13204009 00000W13204006 00000W13204005 00000W13204004 00000LA70D10E6 00000M10162002 00000G10161003 00000F10173001 00000Q11152001 00000N11330003 00000M11363001 00000Q11048002 000000L9343006 0000AX12262005 0000AX12262004 0000AE12041002 00000Q11060005 00000Q11060003 00000E10336010 00000E10336004 00000A10299005 00000A10299004 0000AQ11291002 0000AN11298002 000000G9337014 00000L3A5249C5 000000L9343002 00000W13028002 00000L10333003 00000L10333002 00000L10333001 00000H12059001 0000AN11298010 0000AN11298009 0000AL12142013 00000N10337011 0000AM12222007 0000AM12222006 00000J12025008 00000J12025007 0000AE12009001 00000P11312002 00000V11143003 00000V11143002 00000U10061002 00000P11146001 00000E10083003 00000E10083002 00000E10083001 00000Z11074003 00000N11028003 0000AF12285001 00000P11312008 00000B11131008 00000LA709D844 000000G9337005 0000AL12145002 0000AL12144007 0000AL12144001 000000L9343007 00000R11055001 00000P10008001 0000AH13150004 0000AH13150003 00000J10208003 00000X13036005 00000F10229004 00000F10229003 00000L0238B1D6 00000S11020009 0000ZA10285001 00000N10337003 00000N10337002 00000A10299001 00000P12242003 000000L9343003 00000M13046006 00000M13046001 00000Q13022009 00000Q13022005 00000Q13022001 0000AP12123006 0000AP12123005 0000AF11249001 00000R12086005 00000P13137003 00000P13137001 00000L13134005 00000F12320003 00000J11237001 0000AB12018002 00000P11312009 0000AC12130006 00000J13032002 000000G9337019 0000AL12145003 0000AL12144008 00000R11027003 00000F10229007 00000F10229006 00000A10299003 00000A10299002 00000T12179002 00000T12179001 000000G9337006 0000AD12038001 00000N12033004 00000N12033003 00000U10258001 00000U10251001 00000F10229005 0000AL12200001 0000AJ12174004 00000A12174013 00000P13105001 00000P13088002 00000F12320011 0000AB10126001 0000AG12165001 00000S13156003 00000D10232002 00000J11003001 000000W9351002 0000AJ12167001 0000AG12165004 0000AG12165003 00000Y12164002 00000M12157002 00000Q11060002 00000N12033002 00000G10312002 00000N12033006 00000R11020002 00000R11020001 00000P11073002 00000Y12340001 00000X11076003 00000E11084001 00000C11087001 0000AJ12174002 00000K12215003 00000A12174005 0000AJ12082005 0000AJ12082004 00000R12086001 00000V11073001 00000L3A9968B7 0000AA11075001 00000J11077002 0000AJ12174003 0000AF12207001 00000N13163003 00000N13163001 0000AH12265003 00000M12272002 00000Q11075001 00000W13031002 00000W13028001 00000U10042001 00000P13070001 00000L3A8FD142 00000S11019001 0000AL12144010 00000Q11173001 0000AB12083001 00000V10334003 00000V10334002 00000T10123003 00000P10159001 00000N13163006 00000N13163005 00000A12174015 00000W11328002 00000U11360001 0000AM12303004 0000AM12303001 00000M13046003 00000270626GE5 00000332780GE6 00000X13107001 00000Z12251005 00000LA70A45D3 0000AN11298001 00000N10337014 0000AH12286002 0000AH12286001 00000T12334001 0000AF11077001 0000AH12265005 00000T12032006 00000Q13022004 00000G10271002 00000G10271001 00000F10281001 0000AC12277003 0000AC12277001 00000M13123012 00000J13175001 00000U12263003 00000U12263002 00000A12174020 00000LA70A4A10 00000L3A5F3C9C 0000AL12233002 0000AL12233001 00000L020E0A85 0000AB12018004 00000Z13168003 00000Z13168002 0000AD12269003 0000AD12269002 00000LE4B6A1CA 00000L3AB2DE60 00000P11312012 0000AL12144002 000000G9337008 0000AM12208001 0000AP12123001 0000AQ11291001 00000T12333004 00000L3A73153D 00000P11312019 00000H13058001 0000AG12118006 00000X13036003 00000W13204008 0000AM12222004 0000AM12222003 00000A12219002 00000A12219001 00000R12086007 00000G13078002 00000G13078005 00000Z12251001 0000AP12123002 00000L02577B48 000000Z9350001 0000AE11294002 00000M13046005 00000LA712358B 00000W10202001 00000H10098001 00000A10194004 00000A10194003 00000A10194002 00000X13036001 00000T13044001 00000R13025001 00000Q13022007 00000P13088001 00000N13024002 00000L13171002 00000G13078003 0000AM12222002 00000LA70A48C3 0000AP12123004 0000AL12144004 00000L3A7315C1 0000AX12262003 0000AM12261001 00000S11020004 00000S11020001 00000N10337018 00000L3A5BF838 00000L3A79AB03 00000L3A5BF827 00000E10336003 00000L3A5BF84E 00000L3A75873B 00000L3A5BF911 00000L3A9CCE94 00000L3A77E646 00000N12146001 00000L8B19A930 0000AG12118002 0000AL12142001 00000X13036002 00000Y12317002 0000AD12202004 0000AC12353003 0000AC12353002 00000L3AB68E28 0000AJ12082001 0000AH12080001 0000AC12353001 00000L0257B583 00000M12048003 00000E12332006 000000L9343010 00000K13143003 00000K13143002 00000K13143001 00000N13024001 00000L10351001 00000H10085001 00000E12332010 0000AQ12290001 0000AN11298006 0000AD12125001 00000L3A5249E5 00000F12320001 00000X12244001 0000AE11234004 0000AD13072001 00000T13073003 00000T13073001 00000Q13074001 00000V10243002 00000V10243001 00000D10232001 00000Q13022006 00000N13064005 00000N13064001 00000N12348004 00000N10127004 00000J13063002 0000AB13113001 00000E12332007 00000L3AB68DBD 0000AC12130002 00000N12146006 00000N11159001 00000M13123005 00000M13123004 00000N10337013 00000N10337004 00000A12219006 00000A12219004 00000A12219003 00000L3AB1F8BA 00000L3A557466 0000AH12265006 00000LA704C005 0000AC13154006 00000Z13168001 00000L3A3C7D9D 00000W13115011 00000L3A9C8A55 00000L3A9C8A23 00000X11076002 00000X11076001 00000W13031001 00000Q11060001 00000N11028002 00000N11028001 00000M11069002 00000L3A70C8C6 00000N10337012 0000AL12142004 0000AL12142003 00000X12040003 00000X12040001 00000U10246001 00000N12348006 00000N12348005 00000L3A4F064F 00000L3A4F0555 00000AE9295001 0000AG12118005 0000AG12118004 0000AG12118003 00000P13151001 0000AD10244002 00000U10251002 00000F10229008 00000G10312004 00000G10312003 00000G10312001 00000W11054001 00000R11031001 00000M11069001 00000L3A2A1F16 00000L3A2A1F15 000000W9351001 00000L3AB68D9B 00000D12363002 00000D12363001 00000N11172003 00000N11172002 0000AL12233005 00000A12219009 00000A12219005 00000L022E5E3B 00000S11049002 00000R11052001 00000L3A2A2083 000000Z9309001 0000AL12142009 0000AE12041001 00000R11027005 00000R11027004 00000Q11070001 00000L3A4F066C 000000L9343001 00000W11054002 00000T11061003 00000T11061001 00000D11066001 00000332781GE4", "center_classification_date": "20131113", "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .", "state": "WI", "product_description": "AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.", "report_date": "20131120", "classification": "Class II", "openfda": {}, "recalling_firm": "GE Healthcare, LLC", "recall_number": "Z-0270-2014", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "66550", "termination_date": "20140731", "more_code_info": "", "recall_initiation_date": "20130919", "postal_code": "53188-1615", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }