{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199415", "product_res_number": "Z-1470-2023", "event_date_initiated": "2023-02-27", "event_date_posted": "2023-04-27", "recall_status": "Open, Classified", "res_event_number": "92012", "product_code": "IZL", "k_numbers": [ "K170858" ], "product_description": "FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams", "code_info": "UDI: (01)04547410425505(11)200701.\nSerial numbers with the last 4 digits ending between ****0001 to ****1993.", "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": "SAME\n617-861-5300", "reason_for_recall": "Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.", "root_cause_description": "Device Design", "action": "FUJIFILM Healthcare Americas Corporation (Fujifilm) issued Urgent Medical Device Recall letter on 2/27/23 via email to Distributors ad end-Users. Letter states reason for recall, health risk and action to take:\nA Fujifilm service engineer will contact your facility to arrange a visit to repair your affected unit(s).\nACTIONS TO BE TAKEN BY THE CUSTOMER/END-USER\n1)Perform an inspection according to the steps outlined below prior to using the product.\na. If there are no abnormalities present during the pre-use inspection the product can continue to be used safely.\nb. Immediately remove the device from use if any abnormalities are observed and report the issueto your Fujifilm service engineer.\n\n2)Coordinate with the Fujifilm service engineer to schedule the correction of your device whencontacted.\n3)Please complete and return the Field Action Verification Form attached on page 6 of this communication. Responding with the information requested is essential for ensuring appropriate action is taken.\n Please contact our field action coordinator, Alicia Martinez, via phone at 973-459-9206 or email at alicia.martinez@fujifilm.com, if you have any further questions regarding this field action.", "product_quantity": "77 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K222896", "K802047", "K894643", "K203667", "K220175", "K251443", "K782155", "K171119", "K921116", "K242515", "K001517", "K213405", "K173187", "K932353", "K240009", "K182207", "K150097", "K253185", "K912400", "K874840", "K173299", "K972204", "K042866", "K873982", "K210982", "K002685", "K945707", "K781705", "K203658", "K843192", "K090322", "K161345", "K043002", "K060566", "K220700", "K970234", "K883092", "K183292", "K200976", "K930049", "K021016", "K894021", "K212515", "K862452", "K222951", "K222353", "K083048", "K242015", "K030494", "K231577", "K792665", "K191813", "K182317", "K141539", "K803103", "K924798", "K122697", "K780947", "K151038", "K182234", "K813128", "K020436", "K241996", "K072392", "K781590", "K070634", "K790673", "K972365", "K781982", "K833226", "K862118", "K253058", "K043062", "K182639", "K211383", "K212940", "K032280", "K090655", "K201575", "K790393", "K891143", "K212291", "K760741", "K032628", "K770903", "K781676", "K111912", "K241505", "K902610", "K052721", "K200637", "K211423", "K121410", "K143537", "K103597", "K250597", "K201488", "K042361", "K173018", "K781030", "K212134", "K945043", "K141885", "K902984", "K170607", "K191025", "K242651", "K142492", "K222339", "K790443", "K082627", "K200726", "K911841", "K875106", "K944442", "K212654", "K120062", "K203782", "K052897", "K162278", "K240841", "K912323", "K090268", "K213568", "K193535", "K101517", "K022337", "K181626", "K250976", "K234108", "K780999", "K953404", "K240284", "K162990", "K202353", "K250750", "K061685", "K042368", "K080701", "K212144", "K251223", "K932106", "K183388", "K140723", "K230581", "K781975", "K233678", "K955036", "K040046", "K041763", "K103522", "K790511", "K790451", "K232185", "K973712", "K071015", "K243473", "K810276", "K100449", "K142383", "K253244", "K063262", "K100400", "K111725", "K931279", "K790392", "K891142", "K191884", "K210479", "K932355", "K930699", "K221081", "K781276", "K062472", "K220678", "K033238", "K192936", "K211473", "K173602", "K181874", "K041922", "K781976", "K122298", "K221803", "K201124", "K260085", "K251710", "K173924", "K191451", "K202350", "K890306", "K213462", "K941363", "K811082", "K080945", "K170755", "K931483", "K771571", "K221417", "K052341", "K143494", "K103476", "K243864", "K953292", "K052001", "K141895", "K893637", "K244049", "K931200", "K921425", "K260236", "K923359", "K092713", "K790512", "K012379", "K153059", "K780313", "K934818", "K932354", "K781425", "K012663", "K850678", "K010304", "K973833", "K910902", "K222258", "K171353", "K162687", "K992229", "K201340", "K833239", "K955095", "K981466", "K170858", "K163063", "K241980", "K192011" ], "registration_number": [ "3014809646", "3000126629", "3007065358", "8030233", "3018077344", "3007836437", "3006551157", "3015223550", "3005246977", "1317307", "3004606964", "3033527770", "3013679558", "3012624817", "3003768251", "3031503890", "1418484", "1225677", "3008496839", "3017375271", "9617251", "3018269927", "3008284470", "3004706313", "3032116890", "9610982", "1219183", "3015276088", "3009001657", "1222777", "1418960", "3023344919", "3009715136", "3005877899", "3009077524", "1418964", "3008044777", "3025442726", "3011416394", "3030089787", "3033525986", "3004977335", "3003775006", "3015502499", "3009134655", "3013779985", "3014209556", "3013677815", "3007734888", "3015537309", "3016674851", "9616047", "3021006193", "3012127758", "3010300212", "3006051164", "3017944270", "3011015597", "3010398867", "3004063527", "3024891354", "2126677", "3005810333", "2433615", "3011491794", "3009717300", "9614430", "3014403439", "3016250464", "9613445", "3023003446", "3001556265", "3006542593", "3012855798", "3011950073", "3029916061", "9615439", "3001722928", "3002707445" ], "fei_number": [ "3014809646", "3003377038", "3000126629", "3007065358", "3018077344", "3002143662", "3002495042", "3001451453", "3007836437", "3006551157", "3015223550", "3005246977", "1317307", "3002175190", "3004606964", "3033527770", "3013679558", "3012624817", "3003768251", "3031503890", "1418484", "3008496839", "3017375271", "3018269927", "3008284470", "3004706313", "1000120772", "3032116890", "1219183", "3015276088", "3009001657", "1418960", "3023344919", "3009715136", "3005877899", "3009077524", "1418964", "3008044777", "3025442726", "3011416394", "3003861317", "3030089787", "3033525986", "3004977335", "3003775006", "3015502499", "3009134655", "3013779985", "3014209556", "3013677815", "3007734888", "3015537309", "3016674851", "3021006193", "3002808139", "3012127758", "3010300212", "3006051164", "3017944270", "3011015597", "3010398867", "3002807605", "3004063527", "3024891354", "2126677", "3005810333", "2433615", "3011491794", "3009717300", "3014403439", "3016250464", "3023003446", "3001556265", "3006542593", "3012855798", "3011950073", "3029916061", "3001722928", "3002707445" ], "device_name": "System, X-Ray, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1720", "device_class": "2" } } ] }