{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "141672", "product_res_number": "Z-0401-2016", "event_date_initiated": "2015-10-23", "event_date_created": "2015-12-10", "recall_status": "Terminated", "event_date_terminated": "2016-05-09", "res_event_number": "72617", "product_code": "JAK", "k_numbers": [ "K133705" ], "product_description": "GE Healthcare, Revolution CT Scanners.\n\n\nRevolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.", "code_info": "Mfg Lot or Serial #\tSystem ID 00000439632CN1\t85109909185 00000439899CN6\t83119074723 00000439913CN5\t83119511730 00000441487CN6\t83130644883 00000441818CN2\t83132979115 00000443068CN2\tGON-1510990 00000439432CN6\t190059CT06 00000440338CN2\t220078CT04 00000441574CN1\t030355CT07 00000441779CN6\tCT441683CN0 00000443105CN2\tCT443038CN5 00000440186CN5\tE416249CT1 00000437461CN7\t519646REVO1 00000442492CN5\tE416249CT2 00000443398CN3\t905521RCT1 441961CN0\tE416249CTE 442082CN4\t403944RCT1 442220CN0\t604988RCT1 442268CN9\t416864RCT1 442573CN2\t604682RCT1 \tAM13ECY81 00000440839CN9\t82421040350 00000441053CN6\t82421040345 00000441107CN0\t82421050106 00000441563CN4\t82421040359 00000441930CN5\t82421040346 00000442030CN3\t82421120479 00000442196CN2\t82421030199 00000442749CN8\t82421040369 00000443203CN5\t82421300072 00000443282CN9\t82421190317 00000443322CN3\t82421120484 00000443348CN8\t82421040370 442794CN4\tGON-1510879 00000442517CN9\tDK1051CT04 00000437837CN8\tM2322254 00000440172CN5\tP4192906 00000441238CN3\tX41944012 00000441687CN1\tM2800929 00000441895CN0\tM41980112 00000442351CN3\tE4191734 00000442588CN0\tM44827197 00000442845CN4\tM5480791 00000439243CN7\tPC3383CT01 00000441264CN9\tHC5284CT04 00000438342CN8\t828210096 00000440967CN8\t835210259 00000442981CN7\t5973CT0019 00000439938CN2\tA5624142 00000437028CN4\tREV001 00000439356CN7\tREV006 00000439639CN6\tREV003 00000439802CN0\tREV002 00000439812CN9\tREV004 00000440092CN5\tREV008 00000440113CN9\tREV005 00000440682CN3\tREV007 00000441280CN5\tREV009 00000441460CN3\tREV011 00000442008CN9\tREV012 00000442404CN0\tREV020 00000443513CN7\tREV014 00000443527CN7\tREV013 00000442704CN3\t850210885 00000442992CN4\t850210884 00000441573CN3\tKW1098CT01 00000442961CN9\tGON-4291498 00000442923CN9\tNO1146CT02 00000442774CN6\tGON-1505695 00000439901CN0\tPL1008CT04 00000440335CN8\tPL1150CT03 00000440624CN5\tSA1012CT10 00000443519CN4\tGON-4326652 00000439695CN8\tD007CT07 00000440805CN0\tA010CT16 00000441378CN7\tA010CT17 00000443442CN9\tGON-1505146 00000443455CN1\tGON-4289981 00000443526CN9\tGON-4289991 00000438864CN1\t900010CT06 00000439199CN1\t260010CT19 00000443665CN5\tGON-4320212 00000442509CN6\t853210292 00000439068CN8\tAE1477CT01 00000440886CN0\t00160CTS03 00000440887CN8\t00243CTS11 00000441017CN1\t00487CTS03 00000443477CN5\tGON-4326453 00000437787CN5\t786596WKRIVO 00000438503CN5\t206598REV1 00000438951CN6\t309655REVCT 00000439029CN0\t801662REV1 00000439160CN3\t212241REVCT 00000439367CN4\t415476MCT3 00000439394CN8\t415476MCT2 00000439736CN0\t940898REVO 00000439838CN4\t703698REVOCT 00000439977CN0\t408356RV1 00000440004CN0\t503216SREV 00000440030CN5\t215662CTREV 00000440053CN7\t715847RCT1 00000441997CN4\tGON-198192509 00000442142CN6\tGON-198967538 00000442229CN1\t408498RV2 00000442295CN2\tGON-201658733 00000443146CN6\t919684REVCT 00000443377CN7\t8588824REVCT 00000443420CN5\t608263REVCT 440707CN8\t815226RVCT 441081CN7\t808522RCT 441165cn8\t256HHRCT1 441199CN7\t414805REVCT 441320CN9\tRMHCTREV 441520CN4\t203688ERREV1 441553cn5\t215952CTREV 441647CN5\t847437ACT7 441739cn0\t217876REVO1 441916CN4\t469841REVO 442050CN1\t206598ERREV 442300CN0\t281274REV 442376CN0\t262574REVO 442719cN1\t727398REVO \t512DELLCT \t205699CTREV \tAM13NAY127", "firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "262-513-4122", "reason_for_recall": "GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.", "root_cause_description": "Software design", "action": "The firm, GE Healthcare, sent an\"Urgent Medical Device Correction\" letter GEHC Ref#25465 dated October 23, 2015 to its Consignees. The letter described the Safety Issues, Safety Instructions, Product Correction, Affected Product Details and Contact Information. The consignees were instructed to follow the instructions in existing CT User Manual and the safety instructions listed in the letter. GE will be delivering an addendum to the User Manual that reiterates these mitigations. \n\nIf you have any questions or concerns regarding this notification, please contact GE\nHealthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "125 (US = 37; OUS = 88)", "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, NY, NC, OH, OR, PA, TX, UT, VA, WA, WI; and countries of: AUSTRALIA, BELGIUM BRAZIL, CANADA, CHINA,DENMARK, FRANCE, GERMANY, HONG KONG, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, NORWAY, PERU, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.", "openfda": { "k_number": [ "K080271", "K884268", "K163643", "K033502", "K221116", "K881305", "K790975", "K201745", "K073003", "K160350", "K163289", "K200626", "K211168", "K250370", "K932848", "K052216", "K243240", "K024149", "K023943", "K090220", "K233731", "K212067", "K875370", "K973168", "K042438", "K051833", "K040902", "K121072", "K063324", "K082104", "K203699", "K172983", "K042328", "K803181", "K061310", "K071806", "K192590", "K012106", "K113732", "K032536", "K130645", "K161009", "K032243", "K110227", "K072574", "K811227", "K013561", "K242874", "K191332", "K151376", "K191468", "K123500", "K150595", "K022326", "K260166", "K151752", "K023785", "K120579", "K260169", "K183143", "K151765", "K081482", "K101888", "K760688", "K982787", "K151673", "K202526", "K022919", "K012836", "K142465", "K031871", "K013422", "K911500", "K982060", "K990426", "K003152", "K062673", "K041267", "K203187", "K894542", "K150565", "K022050", "K223804", "K761330", "K950972", "K053046", "K061187", "K173607", "K935454", "K062351", "K173468", "K151533", "K243398", "K183202", "K253560", "K244008", "K250766", "K940606", "K982349", "K790134", "K260167", "K182716", "K192956", "K073138", "K092747", "K182901", "K233750", "K082960", "K812509", "K091673", "K133640", "K241166", "K944131", "K192828", "K944326", "K063241", "K023687", "K010813", "K120300", "K171183", "K160587", "K203411", "K203617", "K232227", "K840860", "K923106", "K163297", "K902557", "K913029", "K133646", "K253770", "K791163", "K211828", "K163284", "K191136", "K771082", "K874767", "K972399", "K134025", "K130552", "K133674", "K863935", "K150757", "K242403", "K060779", "K033326", "K984634", "K132410", "K231281", "K982536", "K052839", "K790342", "K141741", "K945512", "K020796", "K160126", "K955268", "K884555", "K150785", "K781431", "K133424", "K122909", "K211645", "K232835", "K131773", "K093995", "K010042", "K790395", "K991600", "K915738", "K123584", "K772125", "K193289", "K924985", "K011160", "K230220", "K090173", "K991764", "K153429", "K160743", "K231574", "K770855", "K201053", "K133324", "K252992", "K091529", "K812241", "K882022", "K191777", "K211180", "K192832", "K241200", "K233583", "K924810", "K201188", "K110812", "K181646", "K081379", "K002978", "K780928", "K214019", "K020929", "K844926", "K153331", "K181414", "K033832", "K882906", "K193281", "K884788", "K083293", "K180225", "K031206", "K921192", "K193267", "K201586", "K891931", "K093146", "K761332", "K120710", "K841997", "K960635", "K250822", "K192763", "K923109", "K201898", "K082220", "K010817", "K170221", "K082761", "K022013", "K974455", "K143294", "K002005", "K980169", "K112989", "K960985", "K092013", "K150745", "K182147", "K200524", "K200515", "K031261", "K080624", "K060937", "K900660", "K000819", "K911501", "K070658", "K161157", "K173625", "K223424", "K251805", "K970999", "K111633", "K884667", "K253649", "K193073", "K131433", "K923111", "K171677", "K240844", "K200990", "K241295", "K871859", "K002258", "K801407", "K123541", "K203720", "K965004", "K941745", "K180901", "K911764", "K190578", "K230807", "K121418", "K872150", "K972903", "K970980", "K163528", "K202213", "K253596", "K200498", "K880965", "K161196", "K073238", "K052260", "K212441", "K854340", "K913485", "K013146", "K250648", "K896456", "K143401", "K183046", "K190841", "K760882", "K100637", "K913491", "K930765", "K052029", "K023760", "K153444", "K013999", "K864046", "K163213", "K183291", "K213649", "K153004", "K091934", "K201836", "K761033", "K063762", "K133901", "K173630", "K992740", "K923108", "K060052", "K161066", "K011447", "K000300", "K780326", "K780115", "K030450", "K123540", "K072606", "K781040", "K093810", "K173632", "K251061", "K850027", "K884671", "K150713", "K161748", "K183548", "K223447", "K023332", "K062386", "K073695", "K173076", "K011180", "K013381", "K983140", "K191394", "K133497", "K171013", "K250928", "K120331", "K123596", "K182223", "K233334", "K183161", "K013521", "K921432", "K173821", "K903701", "K961464", "K230112", "K142584", "K163281", "K073373", "K233657", "K980837", "K943623", "K192686", "K081022", "K213715", "K970606", "K240369", "K912454", "K963896", "K862317", "K253686", "K934832", "K973908", "K020385", "K923114", "K792603", "K083498", "K913352", "K132222", "K132813", "K220814", "K080540", "K875088", "K781936", "K232206", "K780480", "K984156", "K813162", "K222361", "K120546", "K234030", "K172188", "K050458", "K974513", "K003230", "K253450", "K153263", "K955255", "K812410", "K012238", "K133373", "K063189", "K230130", "K121827", "K843927", "K093891", "K935487", "K110366", "K151283", "K211591", "K020913", "K852865", "K780737", "K904971", "K072693", "K973329", "K032915", "K252217", "K040782", "K050297", "K110066", "K012009", "K772289", "K003639", "K171022", "K183268", "K061625", "K102102", "K902848", "K091195", "K923524", "K153360", "K083282", "K092742", "K230223", "K243617", "K982583", "K132523", "K213504", "K243229", "K130960", "K973327", "K910375", "K021491", "K031469", "K210085", "K022354", "K191550", "K872615", "K211373", "K032823", "K211711", "K221219", "K870513", "K250650", "K233875", "K872526", "K060903", "K260078", "K972879", "K170019", "K152473", "K153220", "K213725", "K223261", "K924082", "K110093", "K213944", "K252249", "K203042", "K241440", "K113421", "K151919", "K760201", "K090504", "K033357", "K121792", "K190505", "K092365", "K071308", "K203020", "K003736", "K040372", "K072841", "K131576", "K243523", "K201092", "K811358", "K802045", "K013214", "K121498", "K061817", "K162302", "K163711", "K220961", "K942040", "K991278", "K172539", "K132902", "K143400", "K193170", "K041542", "K133705", "K230421", "K102259", "K080211", "K040665", "K030420", "K123576", "K220450", "K043086", "K772291", "K173478", "K232155", "K150104", "K053210", "K250941", "K083227", "K903763", "K203514", "K913996", "K772198", "K913252", "K212889", "K232045", "K193293", "K232392", "K183204", "K091103", "K142955", "K150003", "K250662", "K143223", "K192427", "K001682", "K033677", "K130224", "K113715", "K122471", "K881674", "K132524", "K772305", "K132108", "K053024", "K163296", "K936272", "K861698", "K833228", "K063184", "K912752", "K133589", "K151749", "K140912", "K012313", "K133648", "K993792", "K243672", "K090462", "K982010", "K133677", "K251484", "K882378", "K203169", "K103127", "K051980", "K991716", "K113466", "K011141", "K203225", "K971717", "K191891", "K180015", "K894887", "K772317", "K120833", "K071378", "K974307", "K052855", "K121553", "K123509", "K061370", "K811723", "K974344", "K122109", "K802206", "K923110", "K042293", "K012385", "K090991", "K161285", "K253026", "K061449", "K213713", "K961055", "K771990", "K971054", "K974715", "K181797", "K242188", "K213759", "K900170", "K081105", "K113342", "K220910", "K233753", "K061834", "K052852", "K152036", "K220986", "K163341", "K141069", "K203216", "K994431", "K964318", "K062315", "K791195", "K102677", "K223726", "K233650", "K233749", "K894888", "K941546", "K130901", "K982265", "K900233", "K113548", "K151372", "K222819", "K213096", "K071310", "K233080", "K212494", "K003408", "K183448", "K062451", "K172058", "K151414", "K223311", "K880822", "K220664", "K140232", "K853444", "K003014", "K894269", "K112020", "K071513", "K771978", "K955253", "K172135", "K893820", "K801446", "K103424", "K193454", "K151833", "K173637", "K884670", "K131431", "K210760", "K791153", "K073153", "K232412", "K013522", "K772123", "K170789", "K050867", "K072737", "K132087", "K162314", "K982631", "K993645", "K113483", "K133590", "K991553", "K230162", "K861708", "K142697", "K123585", "K083524", "K902643", "K052587", "K170273", "K010641", "K180727", "K903622", "K980176", "K093787", "K133649", "K170238", "K233698", "K192402", "K033418", "K162838", "K192061", "K250970", "K970819", "K113287", "K170177", "K113063", "K063507", "K242411", "K041521", "K241757", "K113341", "K964747", "K133603", "K173244", "K964583", "K171201", "K052157", "K812393", "K954255", "K213999", "K022239", "K223028", "K183271", "K251645", "K053148", "K232136", "K150665", "K770573", "K230370", "K911387", "K102604", "K081847", "K082816", "K063029", "K171198", "K133643", "K232491", "K193277", "K915623", "K093581", "K923077", "K760808", "K790942", "K043111", "K932508", "K212875", "K051765", "K944983", "K771811", "K053610", "K033774", "K032475", "K944013", "K001088", "K052447", "K143409", "K160723", "K180393", "K201034", "K043087", "K242811", "K040577", "K171738", "K884668", "K082458", "K103489", "K201231", "K964746", "K152584", "K014240", "K171850", "K990134", "K993791", "K232022", "K882581", "K213927", "K241079", "K231482", "K253574", "K143416", "K033102", "K964890", "K120910", "K122106", "K200016", "K000359", "K884669", "K022794", "K955583", "K241713", "K812400", "K820688", "K151383", "K781752", "K213465", "K223758", "K955254", "K930090", "K780930", "K171261", "K170023", "K253173", "K040224", "K982004", "K885322", "K080581", "K213938", "K024171", "K043469", "K222360", "K914305", "K780769", "K991766", "K231631", "K042229", "K073346", "K213829", "K203448", "K221727", "K120796", "K813196", "K253520", "K170716", "K233767", "K910859", "K192188", "K160611", "K142222", "K223514" ], "registration_number": [ "", "3033527283", "2134243", "8043933", "3026047529", "3007225492", "3015537315", "3013847349", "3009529630", "3029521953", "3010789868", "3027338963", "3007233544", "3011825597", "3012085143", "3002808157", "3004091527", "3003678543", "3005930550", "3012044688", "1047843", "2134213", "3019216", "3011050570", "3036666444", "3016965352", "3004056159", "3008114965", "3009963139", "3010123525", "3006487372", "1066019", "3003967489", "3009543051", "3010642685", "3009077524", "3011015597", "3033527241", "3003202425", "3018596740", "9612283", "3017425975", "3007797756", "3016007746", "3002807636", "2011171", "3014246639", "2520313", "2134850", "3018094310", "3011802799", "3008355361", "3031503890", "2032112", "3011797532", "3004962788", "3005156333", "3011642792", "1423253", "3004938766", "3017500061", "2247992", "3006610845", "3015169361", "3011416394", "3017426576", "3018423337", "3010281549", "3008007310", "1000246715", "3013035022", "3008632256", "9613299", "3015276088", "3008284470", "3013875850", "3023140882", "3012127758", "3023003446", "1317307", "3010601176", "3032109181", "3012938564", "3030982377", "1834003", "3012957335", "3013679558", "3010326005", "3003575350", "3010703925", "3027339477", "3012453401", "3010398867", "3017210169", "3017375271", "3006209933", "3027245002", "3000126629", "3002907620", "3027373189", "8043728", "3043512431", "3033524251", "9613445", "3007562060", "3005810333", "3015777306", "3014134519", "3015060224", "3004198450", "3009154005", "3014938447", "3008496839", "3009196578", "2126677", "3014653800", "3004977335", "3011396687", "1034973", "3004753774", "9614698", "3011950073", "3004083736", "3015232217", "1054713", "3017894900", "3010151377", "3039211310", "3012761544", "3005877899", "1811755", "8022257", "3001722928", "3015763655", "3042175844", "3021059265", "3035950510", "3032109225", "9617978", "9616567", "3016619943", "3006621332", "3014343100", "3014809646", "3004857110", "3033527282", "3003477135", "3006894636", "1123169", "2183744", "1226188", "3003094912", "3042172882", "3026970882", "3012939903", "2030624", "9611343", "3004993756", "3015223550", "3026391023", "3007545404", "3008769756", "3023460764", "3011786147", "3003768277" ], "fei_number": [ "", "3033527283", "3026047529", "3007225492", "3015537315", "3013847349", "3009529630", "3029521953", "3010789868", "3027338963", "3007233544", "3011825597", "3012085143", "3002808157", "3004091527", "3003678543", "3005930550", "3012044688", "1047843", "3003079232", "3001654007", "3019216", "3011050570", "3036666444", "3016965352", "3004056159", "3008114965", "3009963139", "3010123525", "3006487372", "3003967489", "3009543051", "3010642685", "3000206435", "1000139922", "3009077524", "3011015597", "3033527241", "3003202425", "3018596740", "3004571294", "3007797756", "3016007746", "1000114111", "3014447948", "3002807636", "2011171", "3003076831", "3014246639", "2520313", "3018094310", "3011802799", "3002619595", "3008355361", "3031503890", "3003757840", "3011797532", "3002807903", "3004962788", "3005156333", "3011642792", "1000284313", "3004938766", "3017500061", "3006610845", "3001726808", "3015169361", "3011416394", "3017426576", "3018423337", "3010281549", "3008007310", "1000246715", "3013035022", "3008632256", "3015276088", "3008284470", "3013875850", "3023140882", "3012127758", "3023003446", "1317307", "3010601176", "3032109181", "3012938564", "3030982377", "3012957335", "3013679558", "3010326005", "3003575350", "3010703925", "1000514697", "3027339477", "3012453401", "3010398867", "3017210169", "3017375271", "3006209933", "3027245002", "3000126629", "3002907620", "3027373189", "3043512431", "3002963732", "3033524251", "3007562060", "3004198450", "3005810333", "3015777306", "3014134519", "3015060224", "3009154005", "3014938447", "3008496839", "3009196578", "3008342029", "2126677", "3014653800", "3004977335", "3011396687", "1034973", "3004753774", "3011950073", "3004083736", "3015232217", "3017894900", "3010151377", "3039211310", "3012761544", "3005877899", "1811755", "3003007876", "1000123143", "3002808529", "1000208827", "3001722928", "3015763655", "3042175844", "3021059265", "3035950510", "3032109225", "3016619943", "3006621332", "3002807880", "3014343100", "3014809646", "3004857110", "3033527282", "3003477135", "3006894636", "2183744", "3003094912", "3042172882", "3002175190", "3026970882", "3012939903", "3008581796", "3004993756", "3015223550", "3026391023", "3007545404", "3002808382", "3008769756", "3023460764", "3011786147" ], "device_name": "System, X-Ray, Tomography, Computed", "medical_specialty_description": "Radiology", "regulation_number": "892.1750", "device_class": "2" } } ] }