{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217665", "product_res_number": "Z-1299-2026", "event_date_initiated": "2026-01-09", "event_date_posted": "2026-02-05", "recall_status": "Open, Classified", "res_event_number": "98124", "product_code": "KPR", "k_numbers": [ "K152294" ], "product_description": "FDR Visionary Suite;\nModel Number: CH-200;\nVersion: (1) 566-16130-23, (2) 566-16130-31, (3)", "code_info": "Model Number: CH-200;\n\n(1) Version: 566-16130-23;\nUDI-DI: 04540217052226;\nSerial numbers: MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001;\n\n(2) Version: 566-16130-31;\nUDI-DI: 04540217057436;\nSerial numbers: MP95AA783001;\n\n(3) Version: 566-16130-33;\nUDI-DI: 04540217057450;\nSerial numbers: MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;", "firm_fei_number": "1000513161", "recalling_firm": "FUJIFILM Healthcare Americas Corporation", "address_1": "81 Hartwell Ave Ste 300 81 Hartwell Ave", "address_2": "Ste 300", "city": "Lexington", "state": "MA", "postal_code": "02421-3160", "additional_info_contact": "Kotei Aoki\n765-246-2931", "reason_for_recall": "It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.", "root_cause_description": "Process control", "action": "On January 9, 2026 URGENT: MEDICAL DEVICE RECALL letters were emailed to customers. Actions to be taken:\nPlease pay attention to the following points until the work is completed.\n\"\tFor safety reasons, please turn off the breaker of the distribution board to which the power cord of the unit is connected after turning off the power of the unit according to the operation manual.\n\"\tDo not forget to turn off the breaker of the distribution board until the replacement of the contactor is completed.\n1)\tPlease post this notification on or near the device \n2)\tPlease complete and return the Field Action Verification Form attached to this communication. Responding with the information requested is essential for ensuring appropriate action is taken.\n3)\tPlease contact Technical Assistance Center (TAC) at 1-888-FUJIMED (1-888-385-4633) to open a service ticket.\n4)\tPlease report any known adverse events to FDA via MedWatch.", "product_quantity": "16 units", "distribution_pattern": "US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.", "openfda": { "k_number": [ "K061595", "K870400", "K071409", "K242847", "K841923", "K012546", "K163410", "K153119", "K193360", "K001341", "K122726", "K980296", "K872317", "K912515", "K163203", "K900562", "K050704", "K872316", "K231892", "K113855", "K110849", "K033577", "K221853", "K935649", "K212186", "K121513", "K150725", "K922813", "K253446", "K063246", "K242478", "K102680", "K001336", "K043025", "K141381", "K214012", "K150816", "K232178", "K942792", "K132934", "K233722", "K933512", "K160997", "K813173", "K163115", "K990715", "K944613", "K071392", "K040995", "K180543", "K941931", "K202293", "K770060", "K182622", "K191418", "K913757", "K220919", "K080614", "K122589", "K120752", "K073632", "K062417", "K872468", "K242019", "K160857", "K072010", "K112670", "K121345", "K031535", "K190601", "K233543", "K781983", "K972000", "K902606", "K151924", "K233719", "K260481", "K102284", "K863309", "K121109", "K102123", "K143270", "K062335", "K970136", "K781613", "K902791", "K883160", "K934755", "K862616", "K122454", "K101435", "K990242", "K203340", "K963941", "K062634", "K812332", "K933778", "K001201", "K981657", "K904676", "K091747", "K022737", "K150165", "K051258", "K182880", "K083181", "K872525", "K251167", "K012165", "K962896", "K083109", "K803049", "K140334", "K810797", "K133259", "K921112", "K973710", "K760205", "K090238", "K172869", "K101042", "K861994", "K242499", "K233920", "K101686", "K062405", "K802200", "K080582", "K082798", "K022667", "K853753", "K233532", "K141837", "K952871", "K231761", "K113248", "K051967", "K071401", "K152767", "K103050", "K242678", "K860025", "K192364", "K811934", "K192079", "K210692", "K242119", "K162971", "K931071", "K853330", "K143029", "K945278", "K013481", "K152294", "K132294", "K233381", "K073114", "K993090", "K941592", "K060550", "K192541", "K071403", "K982824", "K080553", "K854110", "K940306", "K982196", "K071408", "K880352", "K191699", "K993665", "K915362", "K083640", "K091889", "K140683", "K973219", "K223842", "K923455", "K083510", "K945709", "K192453", "K811230", "K202156", "K150506", "K852349", "K192293", "K102285", "K981880", "K173612", "K181279", "K193225", "K083503", "K201825", "K082261", "K122119", "K142930", "K181413", "K182647", "K123098", "K123105", "K133695", "K904147", "K082064", "K081722", "K912517", "K173823", "K012389", "K182517", "K173517", "K811215", "K974597", "K201640", "K150663", "K071546", "K954196", "K202388", "K974112", "K913711", "K151219", "K952672", "K811142", "K950980", "K880982", "K073650", "K833559", "K193574", "K152813", "K904146", "K182183", "K252000", "K072867", "K790741", "K033345", "K111655", "K220149", "K162224", "K173953", "K120034", "K250790", "K202394", "K926554", "K102408", "K800564", "K811807", "K050151", "K984111", "K183541", "K072659", "K213700", "K241068", "K200944", "K103448", "K110828", "K810973", "K230800", "K790070", "K771051", "K250788", "K902378", "K071402", "K921539", "K945708", "K121854", "K233530", "K180765", "K203537", "K123106", "K790069", "K052943", "K013826", "K913659", "K926069", "K133496", "K102349", "K220271", "K203345", "K142049", "K953832", "K151685", "K042876", "K071430", "K142773", "K981056", "K250738", "K223550", "K133959", "K972766", "K260482", "K190330", "K230241", "K193637", "K182134", "K233662", "K904145", "K870300", "K080655", "K974863", "K884477", "K090279", "K143257", "K152788", "K140332", "K781473", "K140326", "K913435", "K201725", "K161937", "K180663", "K933023", "K093816", "K011111", "K803130", "K092830", "K260488", "K920558", "K790740", "K191879", "K841756", "K800788", "K910757", "K070678", "K162529", "K172229", "K052541", "K883834", "K982955", "K193089", "K993962", "K201373", "K023008", "K791374", "K173828", "K202572", "K992066", "K092307", "K063247", "K160620", "K942581", "K920347", "K220518", "K855161", "K091752", "K790685", "K151419", "K990298", "K936087", "K231995", "K181629", "K223060", "K081836", "K213057", "K011486", "K201670", "K152244", "K934005", "K250954", "K082604", "K101779" ], "registration_number": [ "3011015597", "3004989804", "2126677", "3011955679", "3015276088", "3005406110", "9613445", "3025442726", "9616014", "3004977335", "3027339477", "3009963139", "3006051164", "3011416394", "8030112", "3014209556", "3012569470", "3033525986", "3011950073", "3009715136", "3031503890", "3003768277", "3006165260", "3033527770", "3006115340", "1064396", "3013714596", "3003202425", "3003768251", "1418964", "1450503", "3001722928", "3000126629", "3009608361", "1418484", "9614430", "1054713", "3009529630", "2433615", "3007305589", "3042864600", "3016674851", "3003775006", "3009001657", "3003769120", "3014293172", "3008364043", "3012127758", "3005810333", "3023003446", "3010300212", "3004756607", "3035950510", "3001556265", "3016250464", "3005172103", "3006551157", "3009077524", "9617251", "3008284470", "3021059265", "3011825597", "3004198450", "3004485675", "8030233", "1317307", "3029916061", "3014403439", "3004077520", "3012624817", "3030089787", "3032116890", "3008496839", "3004606964", "3024891354", "3023190435", "3009134655", "9616047", "3009717300", "8022065", "3013679558", "2243057", "3005778458" ], "fei_number": [ "3011015597", "3005116291", "3004989804", "2126677", "3011955679", "3015276088", "3005406110", "3025442726", "3002885429", "3004977335", "3002175190", "3027339477", "3009963139", "3002143662", "3006051164", "3011416394", "3014209556", "3012569470", "3033525986", "3011950073", "3009715136", "3031503890", "3006165260", "3033527770", "3006115340", "3013714596", "3003202425", "3003768251", "1418964", "1450503", "3001722928", "3000126629", "3009608361", "1418484", "3009529630", "2433615", "3007305589", "3042864600", "3016674851", "3003775006", "3009001657", "3003769120", "3014293172", "3008364043", "3012127758", "3005810333", "3023003446", "3010300212", "3002807880", "3004756607", "3035950510", "3001556265", "3016250464", "3005172103", "3006551157", "3009077524", "3011825597", "3008284470", "3021059265", "3002495042", "3003377038", "3004198450", "3003434037", "3004485675", "3002675731", "1317307", "3029916061", "3014403439", "3004077520", "3012624817", "3030089787", "3032116890", "3008496839", "3004606964", "3024891354", "3023190435", "3009134655", "3009717300", "1000114111", "3013679558", "2243057", "3002808139", "3005778458" ], "device_name": "System, X-Ray, Stationary", "medical_specialty_description": "Radiology", "regulation_number": "892.1680", "device_class": "2" } } ] }