{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203872", "product_res_number": "Z-0223-2024", "event_date_initiated": "2023-10-05", "event_date_posted": "2023-11-14", "recall_status": "Open, Classified", "res_event_number": "93304", "product_code": "IZL", "k_numbers": [ "K111912" ], "product_description": "Mobilett Mira wireless (VA20) mobile x-ray system(s)", "code_info": "Model Number \n10273100 / UDI 04056869009117\n\nSerial \n1511\n2168\n2525\n2633", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "city": "Malvern", "state": "PA", "postal_code": "19355-1418", "additional_info_contact": "Rebecca Tudor\n484-323-4198", "reason_for_recall": "Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.", "root_cause_description": "Nonconforming Material/Component", "action": "Customer notification by means of a Customer Safety Advisory Notice (via electronic mail or FedEx) alerting customers to the lack of acoustic signal issue and providing instructions to monitor the visual indicator (exposure LED light) to avoid additional, unnecessary x-ray dose. The CSAN also includes the plan for the affected D810 boards. The boards (containing the faulty mounting of the buzzer) will be replaced, free of charge, at the customer site with field corrective action XP042/23/P. There is no software update.", "product_quantity": "4 distributed in U.S.", "distribution_pattern": "US Nationwide - Worldwide", "openfda": { "k_number": [ "K170607", "K781676", "K862118", "K203658", "K191025", "K173187", "K240841", "K232185", "K234108", "K781425", "K001517", "K162278", "K142492", "K022337", "K052897", "K111725", "K210982", "K002685", "K955095", "K923359", "K203667", "K240284", "K222896", "K781705", "K790451", "K972204", "K930699", "K222258", "K202350", "K970234", "K931279", "K781982", "K873982", "K212291", "K811082", "K121410", "K062472", "K201575", "K810276", "K202353", "K222339", "K242515", "K790392", "K090655", "K780313", "K182234", "K891143", "K082627", "K052721", "K012663", "K992229", "K912400", "K052001", "K211423", "K760741", "K212515", "K250750", "K221803", "K181626", "K211473", "K060566", "K071015", "K251443", "K780999", "K111912", "K212134", "K771571", "K061685", "K191451", "K924798", "K070634", "K200976", "K250597", "K894021", "K220678", "K200726", "K803103", "K931483", "K032280", "K143494", "K090268", "K781976", "K251710", "K212654", "K212144", "K182639", "K212940", "K141895", "K230581", "K894643", "K891142", "K181874", "K153059", "K182317", "K173299", "K250976", "K183388", "K242651", "K103522", "K781590", "K101517", "K200637", "K211383", "K120062", "K910902", "K201124", "K921425", "K170858", "K222951", "K191884", "K042361", "K222353", "K945707", "K083048", "K781030", "K932355", "K780947", "K220175", "K122298", "K911841", "K981466", "K953292", "K213568", "K042368", "K930049", "K945043", "K012379", "K213462", "K781276", "K042866", "K802047", "K122697", "K243864", "K944442", "K151038", "K790673", "K173924", "K043002", "K192936", "K240009", "K021016", "K063262", "K862452", "K243473", "K171119", "K100400", "K040046", "K140723", "K072392", "K875106", "K182207", "K833239", "K231577", "K902984", "K253185", "K221081", "K221417", "K233678", "K041922", "K260236", "K850678", "K171353", "K912323", "K790511", "K973712", "K931200", "K790512", "K010304", "K253058", "K100449", "K790393", "K244049", "K242015", "K833226", "K253244", "K210479", "K080945", "K201340", "K033238", "K883092", "K941363", "K251223", "K032628", "K770903", "K143537", "K874840", "K052341", "K781975", "K955036", "K103476", "K792665", "K201488", "K173018", "K890306", "K191813", "K162687", "K972365", "K932106", "K934818", "K080701", "K241980", "K150097", "K813128", "K893637", "K192011", "K103597", "K162990", "K183292", "K141539", "K843192", "K163063", "K220700", "K092713", "K161345", "K921116", "K043062", "K041763", "K142383", "K090322", "K030494", "K790443", "K782155", "K020436", "K932353", "K260085", "K973833", "K932354", "K902610", "K213405", "K953404", "K241996", "K241505", "K203782", "K173602", "K193535", "K141885", "K170755" ], "registration_number": [ "3004606964", "3017375271", "3009077524", "3024891354", "3011491794", "2433615", "3012855798", "3006542593", "9613445", "3011950073", "3008496839", "3013779985", "3025442726", "3003768251", "3008044777", "9614430", "3004706313", "3007065358", "3008284470", "3013679558", "3015502499", "3015223550", "3014809646", "3003775006", "8030233", "3018077344", "3007836437", "3000126629", "3014403439", "3017944270", "3032116890", "3015276088", "3021006193", "3009717300", "3010398867", "3001556265", "3023344919", "3005246977", "3012127758", "3011015597", "3004063527", "3009134655", "3023003446", "9616047", "3007734888", "1225677", "3009715136", "1317307", "3001722928", "1222777", "1418960", "2126677", "3010300212", "3015537309", "9617251", "3009001657", "3006551157", "3012624817", "3004977335", "3031503890", "3005877899", "3006051164", "9615439", "3002707445", "3016250464", "1418964", "3013677815", "3014209556", "3018269927", "3033527770", "1219183", "3005810333", "3033525986", "3016674851", "1418484", "3011416394", "3029916061", "9610982" ], "fei_number": [ "3004606964", "3017375271", "3009077524", "3024891354", "3011491794", "2433615", "3012855798", "3006542593", "3011950073", "3008496839", "3013779985", "3025442726", "3003768251", "3008044777", "3004706313", "3007065358", "3002175190", "3008284470", "3013679558", "3002807605", "3015502499", "3015223550", "3014809646", "3003775006", "3018077344", "3007836437", "3000126629", "3014403439", "3017944270", "3001451453", "3015276088", "3032116890", "3021006193", "3009717300", "3010398867", "3001556265", "3023344919", "3005246977", "1000120772", "3012127758", "3011015597", "3004063527", "3009134655", "3023003446", "3003861317", "3007734888", "3002143662", "3009715136", "1317307", "3001722928", "1418960", "2126677", "3010300212", "3015537309", "3009001657", "3006551157", "3012624817", "3002808139", "3004977335", "3031503890", "3005877899", "3006051164", "3003377038", "3002495042", "3002707445", "3016250464", "1418964", "3013677815", "3014209556", "3018269927", "3033527770", "1219183", "3005810333", "3033525986", "3016674851", "1418484", "3011416394", "3029916061" ], "device_name": "System, X-Ray, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1720", "device_class": "2" } } ] }