{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "131705", "product_res_number": "Z-0453-2015", "event_date_initiated": "2014-09-04", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2015-01-21", "res_event_number": "69286", "product_code": "OWB", "k_numbers": [ "K052412" ], "product_description": "Innova 4100IQ\n\nIndicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.", "code_info": "Mfg Lot or Serial #\tSystem ID 00000583668BU9\t610983INNOVA3 00000643314BU8\t082406090024 00000644609BU0\t082406210011 00000645290BU8\t082406110006 00000645780BU8\t082406040032 00000648200BU4\t082406070014", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "800-437-1171", "reason_for_recall": "Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.", "root_cause_description": "Device Design", "action": "Consignees were sent on 9/4/2014 a GE Healthcare \"Urgent Medical Device Correction\" letter GEHC Ref#12218 dated September 4, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers are to perform a system functional check as instructed in the letter. If the check fails, they should contact their local GE Healthcare Service Representative. GE Healthcare will correct all systems at no cost to the customer, and a representative will contact customers to arrange for the correction. For questions they can call US 800-437-1171. For other countries they can call their local GE Healthcare Service Representative.", "product_quantity": "6 (1 US, 5 OUS)", "distribution_pattern": "Worldwide Distribution -- US, including the states of CA, CO, FL, MO, PA; and, the countries of BELGIUM, CHINA, COLOMBIA, FRANCE, GREECE, MEXICO, and RUSSIA.", "openfda": { "k_number": [ "K231692", "K183109", "K251523", "K210900", "K171829", "K232344", "K021049", "K032761", "K240199", "K051064", "K212523", "K092004", "K200917", "K133278", "K202547", "K220946", "K173736", "K181550", "K982993", "K200074", "K212212", "K032046", "K252099", "K041931", "K212159", "K993037", "K160279", "K130893", "K230871", "K181670", "K260607", "K961105", "K182415", "K181407", "K190768", "K172180", "K150967", "K061173", "K212383", "K092438", "K222998", "K141979", "K163286", "K181830", "K251893", "K193230", "K132094", "K171565", "K243303", "K172863", "K061953", "K242731", "K203551", "K133580", "K090590", "K052412", "K213479", "K172646", "K030061", "K152928", "K232298", "K220311", "K170130", "K092439", "K142126", "K223409", "K041605", "K200218", "K961374", "K241572", "K052202", "K024200", "K160455", "K220627", "K042053", "K173433", "K070834", "K142740", "K181415", "K221281", "K222080", "K203281", "K142243", "K190626", "K033244", "K240224", "K222070", "K132305", "K963952", "K201172", "K210055", "K212336", "K210307", "K251520", "K023178", "K033737", "K140138", "K120073", "K243328", "K112180", "K151000", "K091918", "K210054", "K153232", "K070123", "K010435", "K173639", "K122644", "K251827", "K142736", "K243646", "K253752", "K190064", "K202360", "K123508", "K043076", "K181966", "K200360", "K974355", "K253670", "K220342", "K022114", "K061163", "K030544", "K161563", "K133292", "K210912", "K213768", "K152697", "K033486", "K123529", "K093066", "K220432", "K100102", "K202431", "K170909", "K191503", "K102529", "K082243", "K250660", "K042793", "K101833", "K103416", "K131263", "K143225", "K254186", "K243884", "K181560", "K161976", "K012490", "K234067", "K254173", "K243735", "K163140", "K201743", "K200887", "K040675", "K223410", "K203504", "K254205", "K050489", "K183144", "K170752", "K171194", "K152785", "K210309", "K162148", "K240020", "K142273", "K082781", "K251602", "K122457", "K061203", "K052884", "K022322", "K233230", "K173664", "K153244", "K133535", "K132970", "K170832", "K181834", "K111551", "K201156", "K093688", "K222625", "K230950", "K992660", "K982427", "K102005", "K233748", "K041780", "K241567", "K221230", "K201583", "K231669", "K212557", "K200663", "K921219", "K992103", "K252503", "K234109", "K121444", "K083725", "K103425", "K022069", "K140041", "K062647", "K061534", "K000221", "K212813", "K183040", "K250282", "K253584", "K160147", "K170144", "K190497", "K011311", "K170800", "K062623", "K151904", "K031637", "K221344", "K120282", "K011292", "K172574", "K113403", "K172700", "K221516", "K180473", "K252068", "K960920", "K211777", "K130638", "K002198", "K200022", "K122234", "K060259", "K230949", "K101868", "K221335", "K221922", "K970734", "K161756", "K252500", "K193326", "K002016", "K162859", "K231700", "K970063", "K211064", "K192182", "K211191", "K161839", "K151598", "K173314", "K250010", "K181804", "K160088", "K250241", "K143281", "K243432", "K183101", "K172822", "K133819", "K132027", "K243411", "K213455", "K181943", "K182546", "K053279", "K232420", "K132147", "K152696", "K233200", "K172307", "K073543", "K912448", "K121772", "K083545", "K211782", "K240099", "K171755", "K111344", "K203535", "K212956", "K252229", "K091658", "K923049", "K162614", "K132558", "K181767", "K243376", "K182086", "K010942", "K142708", "K252735", "K211780", "K251199", "K041932", "K230185", "K230787", "K243446", "K251992", "K203623", "K113027", "K173631", "K212442", "K080847", "K993687", "K233107", "K123226", "K141574", "K936180", "K231701", "K153147", "K163715", "K220409", "K240465", "K983069", "K081073", "K013608", "K181403" ], "registration_number": [ "", "3012624817", "3011950073", "8043933", "3005172103", "3026391023", "3009001657", "3012761544", "3010162973", "3043048939", "3012127758", "3013944123", "3012957335", "3031503890", "3003775006", "3008632256", "3014328942", "3011015597", "3008284470", "3027373189", "3023003446", "3014391847", "1052701", "3047842058", "3010703925", "1054713", "3014343100", "3036666444", "3018077344", "3033525987", "3035950510", "3006128100", "1225677", "3021559833", "3003768277", "3001722928", "3008044777", "3005843418", "3012631246", "3030691709", "9613445", "9681146", "3016619943", "3003202425", "3033527282", "3006972752", "1720753", "3011240766", "3012911444", "3010685285", "3004198450", "1000188474", "3009144915", "3011416394", "3021059265", "3006544299", "3010462278", "3015223550", "3042175844", "2247992", "1000181430", "2939520", "3005877899", "3018094310", "3015232217", "3011491794", "3033527770", "3015437189", "3005810333", "3000126629", "3021060474", "3008363989", "2027062", "9611343", "3017375271", "3004785967", "2243057", "3030412764", "1835251", "3009715136", "3013184485", "3030089787", "3008496839", "3016438694", "1047843", "3008253300", "3027339477", "3009196578", "3009077524", "3011713200", "3003477135", "3009963139", "3004754211", "3033525986", "3004977335", "3003935342", "3038614464", "3018596740", "3004026651", "3022378058", "3025394757", "3009973505", "1056553", "3011347852", "3003768251", "3036255956", "2133772", "9614698", "2031966", "1723170", "3019878714", "3010398867", "3015276088", "3012939903", "3021027284", "3014279513", "3005706667", "3002466018", "8030233", "2027467", "1037955" ], "fei_number": [ "", "3012624817", "3011950073", "3005172103", "3026391023", "1000284313", "3009001657", "3012761544", "3043048939", "3012127758", "3013944123", "3012957335", "3031503890", "3002807041", "3003775006", "3008632256", "3014328942", "3011015597", "3008284470", "3027373189", "3023003446", "3014391847", "3047842058", "3010703925", "3014343100", "3002808139", "1000517638", "3036666444", "3018077344", "3033525987", "3035950510", "3006128100", "1000582291", "3021559833", "3001722928", "3008044777", "3005843418", "3012631246", "3030691709", "3016619943", "3003202425", "3033527282", "3006972752", "1720753", "3011240766", "3012911444", "3010685285", "3004198450", "1000188474", "3009144915", "1000208827", "3000209794", "3011416394", "3021059265", "3006544299", "3010462278", "3015223550", "1000132370", "3042175844", "1000181430", "2939520", "3005877899", "3018094310", "3015232217", "3011491794", "3002808382", "3033527770", "3015437189", "1000114111", "3005810333", "3000126629", "3021060474", "3008363989", "2027062", "3017375271", "3004785967", "2243057", "3030412764", "3009715136", "3013184485", "3030089787", "3008496839", "3016438694", "1047843", "3008253300", "3027339477", "3009196578", "3009077524", "3011713200", "3003477135", "3009963139", "3004754211", "3033525986", "3004977335", "3003935342", "3038614464", "3005430103", "3018596740", "3000205591", "3022378058", "3025394757", "3009973505", "3002175190", "3011347852", "3003768251", "3036255956", "3002807880", "3002619595", "3019878714", "1000222289", "3010398867", "3015276088", "3001451453", "3002980729", "3012939903", "3021027284", "3014279513", "3005706667", "3002466018", "2027467", "1037955" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }