{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184407", "product_res_number": "Z-0534-2021", "event_date_initiated": "2020-11-09", "event_date_created": "2020-12-04", "recall_status": "Open, Classified", "res_event_number": "86734", "product_code": "IZL", "k_numbers": [ "K080701" ], "product_description": "Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.", "code_info": "SMS ID / Serial Number  SMS20200126\t41F41E7A3011, SMS20200182\t41F41E7A5006, SMS20200184\t41F41E7A5008, SMS20180073\t41F41DD7C006, SMS20180068\t41F41DD7C003, SMS20180075\t41F41DD7C007, SMS20180349\t41F41DD85007, SMS20180350\t41F41DD85009, SMS20180351\t41F41DD86007, SMS20180448\t41F41DD88001, SMS20190308\t41F41E798002, SMS20190335\t41F41E799002, SMS20190383\t41F41E79A010, SMS20200033\t41F41E79B001, SMS20200034\t41F41E79B005, SMS20200219\t41F41E7A6012, SMS20200301\t41F41E7A6051, SMS20200339\t41F41E7A7006, SMS20190016\t41F41DD88010, SMS20190138\t41F41DD8B007, SMS20190268\t41F41E797001, SMS20190307\t41F41E798003, SMS20200211\t41F41E7A6005, SMS20200232\t41F41E7A6020, SMS20200236\t41F41E7A6024, SMS20200244\t41F41E7A6025, SMS20200245\t41F41E7A6026, SMS20180141\t41F41DD83007, SMS20190008\t41F41DD88007, SMS20190009\t41F41DD88008, SMS20200325\t41F41E7A6055, SMS20180076\t41F41DD81002, SMS20190212\t41F41DD8C012, SMS20200059\t41F41E7A1007, SMS20200212\t41F41E7A6010, SMS20200279\t41F41E7A6041, SMS20200324\t41F41E7A7002, SMS20200332\t41F41E7A7005, SMS20200332\t41F41E7A7005, SMS20190129\t41F41DD8A018, SMS20190213\t41F41DD8C013, SMS20200095\t41F41E7A2004, SMS20200087\t41F41E7A2006, SMS20200088\t41F41E7A2007, SMS20200116\t41F41E7A3002, SMS20200117\t41F41E7A3003, SMS20180205\t41F41DD83023, SMS20180230\t41F41DD84006, SMS20190171\t41F41DD8C002, SMS20190045\t41F41DD89003, SMS20180374\t41F41DD87004, SMS20200159\t41F41DD87004, SMS20190189\t41F41DD8C008, SMS20180117\t41F41DD82008, SMS20180096\t41F41DD82009, SMS20180097\t41F41DD82010, SMS20180185\t41F41DD83019, SMS20200129\t41F41E7A4002, SMS20200130\t41F41E7A4003, SMS20200131\t41F41E7A4004, SMS20200132\t41F41E7A4005, SMS20200206\t41F41E7A6004, SMS20180242\t41F41DD84019, SMS20190076\t41F41DD89010, SMS20190113\t41F41DD8A009, SMS20190092\t41F41DD89013, SMS20200208\t41F41E7A6002, SMS20180066\t41F41DD7C004, SMS20180067\t41F41DD7C005, SMS20190367\t41F41E799010, SMS20190075\t41F41DD89009, SMS20200096\t41F41E7A2005, SMS20200280\t41F41E7A6042, SMS20200348\t41F41E7A7004, SMS20180115\t41E09E963008, SMS20180082\t41F41DD81005, SMS20180245\t\t41F41DD85003, SMS20190160\t\t41F41DD8B014, SMS20200165\t\t41F41E7A4016, SMS20200271\t\t41F41E7A6035, SMS20180065\t\t41F41DD7C002, SMS20180104\t\t41F41DD82011, SMS20200021\t\t41F41E79B003, SMS20200040\t\t41F41E7A1006, SMS20200042\t\t41F41E7A1001, SMS20200148\t\t41F41DD81010,, SMS20180129\t\t41F41DD83001, SMS20180130\t\t41F41DD83002, SMS20180131\t\t41F41DD83003, SMS20180132\t\t41F41DD83004, SMS20180133\t\t41F41DD83005, SMS20180158\t\t41F41DD83008, SMS20180159\t\t41F41DD83009, SMS20180177\t\t41F41DD83015, SMS20180178\t\t41F41DD83016, SMS20190344\t\t41F41DD7C003, SMS20180261\t\t41F41DD85005, SMS20180262\t\t41F41DD85006, SMS20200043\t\t41F41E7A1002, SMS20200044\t\t41F41E7A1003, SMS20200067\t\t41F41E7A1004, SMS20200055\t\t41F41E7A1009, SMS20200062\t\t41F41E7A1010, SMS20180206\t\t41F41DD83026, SMS20180237\t\t41F41DD84013, SMS20180238\t\t41F41DD84014, SMS20190003\t\t41F41DD88004, SMS20200240\t\t41F41E7A6029, SMS20200241\t\t41F41E7A6030, SMS20200078\t\t41F41E7A6032, SMS20180077\t\t41F41DD81001, SMS20180078\t\t41F41DD81003, SMS20200022\t\t41F41E79B004, SMS20200227\t\t41F41E7A6016", "firm_fei_number": "1000125362", "recalling_firm": "Shimadzu Medical Systems", "address_1": "20101 S Vermont Ave", "city": "Torrance", "state": "CA", "postal_code": "90502-1328", "additional_info_contact": "Shimadzu Medical Systems National Technical Support\n844-487-2767", "reason_for_recall": "There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.", "root_cause_description": "Device Design", "action": "Shimadzu issued a \"Urgent: Voluntary Medical Device Recall Notice\" on 11/09/2020\" via email. In addition to informing consignees about the recalled device, the notification letter asked consignees to take the following actions:\n\n1. If your unit is on the affected list, then please check the drive handle assembly to see if the bolts have loosened. If you feel there is a problem with the mobile drive and movement, please discontinue use of the system and contact your local service provider. \n\n2. Shimadzu has identified the affected units and informed your authorized service representative. They will be contacting you to schedule time to implement the corrective action. If you do not receive a call or visit concerning this matter, please contact Shimadzu National Support.\n\n3. Please complete the \"Medical Device Recall Return Response\" form and email to drodriguez@shimadzu-usa.com\n\n4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.", "product_quantity": "115 units", "distribution_pattern": "US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI.", "openfda": { "k_number": [ "K953292", "K790512", "K240284", "K911841", "K873982", "K203667", "K211423", "K850678", "K242515", "K931279", "K981466", "K090655", "K955036", "K222951", "K902984", "K082627", "K141885", "K790673", "K063262", "K241996", "K103597", "K780999", "K141539", "K781030", "K253185", "K043062", "K992229", "K781982", "K930699", "K162990", "K191451", "K042866", "K833239", "K120062", "K941363", "K201124", "K243473", "K810276", "K843192", "K200637", "K070634", "K090322", "K012379", "K001517", "K080701", "K143494", "K760741", "K251710", "K902610", "K210479", "K122697", "K802047", "K923359", "K930049", "K071015", "K122298", "K213462", "K253244", "K253058", "K040046", "K192011", "K191813", "K030494", "K111725", "K212134", "K862452", "K212515", "K890306", "K250976", "K061685", "K142492", "K143537", "K183292", "K200726", "K780947", "K243864", "K894643", "K072392", "K955095", "K163063", "K912323", "K781975", "K875106", "K790451", "K211473", "K103476", "K931200", "K202350", "K972204", "K833226", "K062472", "K100449", "K042368", "K910902", "K033238", "K012663", "K945043", "K790443", "K181626", "K170607", "K121410", "K931483", "K811082", "K022337", "K790511", "K780313", "K813128", "K912400", "K790393", "K052341", "K213405", "K183388", "K100400", "K241980", "K193535", "K232185", "K781705", "K200976", "K260236", "K182207", "K231577", "K894021", "K171353", "K921425", "K220175", "K173018", "K103522", "K250597", "K171119", "K173187", "K781590", "K021016", "K234108", "K251443", "K251223", "K953404", "K173299", "K790392", "K932354", "K970234", "K222353", "K893637", 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"K891143", "K781976", "K151038", "K181874" ], "registration_number": [ "3015537309", "3015223550", "1418964", "3008284470", "3006551157", "3007065358", "8030233", "9615439", "3012127758", "3015276088", "3009717300", "3015502499", "3025442726", "3033527770", "3005246977", "3009134655", "3011015597", "3011950073", "3021006193", "3004063527", "3013677815", "1418960", "2126677", "3017944270", "3007836437", "3003768251", "3012855798", "3003775006", "3011491794", "3005810333", "3018077344", "1219183", "3032116890", "9617251", "3006051164", "1317307", "3010398867", "9616047", "3010300212", "3033525986", "1222777", "3004977335", "3023003446", "3013679558", "1225677", "3007734888", "3011416394", "3014809646", "3013779985", "3009077524", "3030089787", "3014403439", "2433615", "3024891354", "9613445", "3001722928", "9610982", "3005877899", "3012624817", "3004606964", "3008496839", "3000126629", "3016250464", "3029916061", "3018269927", "3016674851", "3006542593", "3004706313", "3009715136", "3001556265", "3031503890", "3014209556", "3009001657", "3008044777", "1418484", "3017375271", "9614430", "3023344919", "3002707445" ], "fei_number": [ "3015537309", "3015223550", "1418964", "3008284470", "3006551157", "3007065358", "3002808139", "3012127758", "3015276088", "3009717300", "3015502499", "3025442726", "3033527770", "3005246977", "3009134655", "3011015597", "3011950073", "3021006193", "3004063527", "3013677815", "3003377038", "3002175190", "1418960", "2126677", "3017944270", "3007836437", "3003768251", "3012855798", "3003775006", "3011491794", "3005810333", "3018077344", "3002143662", "3002807605", "3032116890", "1219183", "3006051164", "1317307", "3010398867", "3010300212", "3033525986", "3004977335", "3023003446", "3013679558", "3001451453", "3007734888", "3011416394", "3014809646", "3013779985", "3009077524", "3030089787", "3014403439", "2433615", "3002495042", "3024891354", "3001722928", "3005877899", "3012624817", "3004606964", "3008496839", "3003861317", "3000126629", "3016250464", "3029916061", "3018269927", "3016674851", "3006542593", "3004706313", "3009715136", "3001556265", "3031503890", "1000120772", "3014209556", "3009001657", "3008044777", "1418484", "3017375271", "3023344919", "3002707445" ], "device_name": "System, X-Ray, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1720", "device_class": "2" } } ] }