{ "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": "95240", "product_res_number": "Z-0447-2011", "event_date_initiated": "2010-10-15", "event_date_posted": "2010-11-23", "recall_status": "Terminated", "event_date_terminated": "2012-06-04", "res_event_number": "57048", "product_code": "IZL", "k_numbers": [ "K092564" ], "product_description": "Medtronic Navigation O-Arm Imaging System, Door Assembly \n(BI-700-00006) used in Product Catalog Numbers:\n9732719,9733346,81-700-00027, 81-700-00027R, 81700-\n00027-100, 81-700-00027-1 OOR, 81-700-00027-120, 81-700-00027-120R, 81700-00027-230, 81-700-00027-230R, 81-700-00027GER, 81-700-00027GERR\n\nIntended use: Designed for 2D fluoroscopic and 3D imaging and is intended to be used by a physician benefits from 2D and 3D information of anatomic structures with high x-ray attenuation such as bony and metallic objects.", "code_info": "All Units distributed from June 2006 through September 2010", "firm_fei_number": "3004785967", "recalling_firm": "Medtronic Navigation, Inc.", "address_1": "300 Foster St", "city": "Littleton", "state": "MA", "postal_code": "01460-2017", "additional_info_contact": "SAME\n978-339-6426", "reason_for_recall": "Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-ARM Imaging System Breakage of the door cable during opening and closing may occur and cause physical harm or delay of therapy", "root_cause_description": "Equipment maintenance", "action": "Medtronic Navigation sent all consignees/customers an \"Urgent Field Safety Notice\" letter dated October 15, 2010. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review and follow the attached information that describes the process to properly detect and proactively manage cable wear; to ensure that the door is completely open when positioning the patient into or removing them from the gantry and when placing the O-ARM Imaging System Tube Drape (BI-900-00003) onto the unit, and report any visual or audible (cracking noise) wear of the cable to Medtronic Representative ASAP. Note: A Medtronic Representative will be contacting the customers within the coming weeks to schedule a time to inspect the current condition of the cable, explain and train the customers on the recommended workflow and inspection procedure and place a permanent label on their O-ARM Imaging System to reinforce these actions. \n\nIf you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or 720-890-3200.", "product_quantity": "244 units", "distribution_pattern": "Worldwide distribution: USA including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, and WI; and countries including: Canada, Austria, Australia, Belgium, Brazil, Libya, South Africa, India, Japan, Singapore South Korea, Haiti, Kuwait, Saudi Arabia, Turkey, UAE, Germany, Netherlands, Great Britain, Italy, Poland, Netherlands, Spain,Sweden, and Switzerland.", "openfda": { "k_number": [ "K911841", "K781975", "K030494", "K240009", "K931483", "K781676", "K192936", "K850678", "K970234", "K141885", "K240841", "K260085", "K161345", "K182639", "K212654", "K061685", "K103522", "K810276", "K781590", "K813128", "K182317", "K232185", "K972365", "K955095", "K012379", "K200637", "K070634", "K103597", "K802047", "K220175", "K780947", "K803103", "K140723", "K242651", "K043062", "K781030", "K923359", "K012663", "K790512", "K253058", "K781276", "K022337", "K873982", "K931200", "K033238", "K052721", "K120062", "K173924", "K790511", "K182234", "K250976", "K192011", "K220678", "K833226", "K780313", "K040046", "K781982", "K891143", "K945707", "K121410", "K141539", "K170858", "K201124", "K893637", "K183388", "K253244", "K142383", "K080701", "K231577", "K862118", "K032628", "K063262", "K042866", "K092713", "K090268", "K891142", "K222951", "K111912", "K213568", "K874840", "K234108", "K242015", "K932355", "K992229", "K932353", "K931279", "K032280", "K043002", "K173187", "K973833", "K220700", "K244049", "K945043", "K143537", "K243864", "K883092", "K902984", "K221081", "K181874", "K103476", "K151038", "K221417", "K213462", "K792665", "K912400", "K771571", "K001517", "K201575", "K222339", "K182207", "K041763", "K250750", "K202353", "K173602", "K222353", "K212291", "K202350", "K062472", "K201340", "K212515", "K790393", "K052341", "K921425", "K213405", "K243473", "K210479", "K183292", "K191813", "K953292", "K944442", "K111725", "K250597", "K912323", "K902610", "K212134", "K972204", "K052897", "K153059", "K042361", "K790392", "K210982", "K141895", "K894643", "K203667", "K241996", "K100449", "K934818", "K941363", "K260236", "K173299", "K042368", "K100400", "K862452", "K200976", "K955036", "K080945", "K090322", "K060566", "K021016", "K875106", "K222258", "K790451", "K253185", "K930049", "K090655", "K072392", "K770903", "K203658", "K052001", "K780999", "K211383", "K162687", "K240284", "K241980", "K212144", "K953404", "K910902", "K171119", "K171353", "K191451", "K973712", "K981466", "K781976", "K211423", "K833239", "K083048", "K101517", "K843192", "K020436", "K201488", "K041922", "K212940", "K930699", "K142492", "K894021", "K191884", "K811082", "K790673", "K251443", "K781425", "K251710", "K170755", "K181626", "K782155", "K122298", "K760741", "K242515", "K211473", "K932354", "K781705", "K200726", "K230581", "K002685", "K082627", "K890306", "K932106", "K191025", "K173018", "K071015", "K170607", "K122697", "K233678", "K251223", "K921116", "K924798", "K193535", "K203782", "K221803", "K222896", "K163063", "K241505", "K143494", "K162278", "K150097", "K162990", "K010304", "K790443" ], "registration_number": [ "9614430", "3012624817", "3006542593", "3011950073", "3015537309", "1219183", "3013779985", "3017944270", "9616047", "3009001657", "3015502499", "3012127758", "3023344919", "3004706313", "2126677", "3031503890", "3003775006", "3014809646", "3011015597", "3008284470", "3023003446", "3021006193", "9617251", "3009717300", "3014209556", "3002707445", "3018077344", "1225677", "1418484", "3016250464", "3001722928", "3008044777", "3010300212", "3018269927", "9613445", "2433615", "3006551157", "1418960", "3006051164", "3004606964", "3007734888", "3011416394", "3009134655", "3013677815", "3015223550", "3005877899", "3011491794", "3033527770", "3005810333", "3000126629", "1418964", "3017375271", "3032116890", "3012855798", "3009715136", "3001556265", "3008496839", "3014403439", "3025442726", "3009077524", "3033525986", "3004977335", "3029916061", "3007836437", "3016674851", "3024891354", "3013679558", "3007065358", "3003768251", "3005246977", "3010398867", "3015276088", "3004063527", "1317307", "9610982", "1222777", "9615439", "8030233" ], "fei_number": [ "3012624817", "3006542593", "3011950073", "3015537309", "1219183", "3013779985", "3017944270", "1000120772", "3009001657", "3002807605", "3015502499", "3012127758", "3002143662", "3023344919", "3004706313", "2126677", "3031503890", "3003775006", "3014809646", "3011015597", "3008284470", "3023003446", "3021006193", "3009717300", "3002808139", "3014209556", "3002707445", "3018077344", "1418484", "3016250464", "3001722928", "3008044777", "3010300212", "3018269927", "2433615", "3006551157", "1418960", "3006051164", "3004606964", "3007734888", "3003861317", "3011416394", "3009134655", "3013677815", "3015223550", "3005877899", "3011491794", "3033527770", "3005810333", "3000126629", "3002495042", "1418964", "3017375271", "3032116890", "3003377038", "3012855798", "3009715136", "3001556265", "3008496839", "3014403439", "3025442726", "3009077524", "3033525986", "3004977335", "3029916061", "3007836437", "3016674851", "3024891354", "3013679558", "3007065358", "3002175190", "3003768251", "3005246977", "3010398867", "3015276088", "3001451453", "3004063527", "1317307" ], "device_name": "System, X-Ray, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1720", "device_class": "2" } } ] }