{ "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": "169254", "product_res_number": "Z-0659-2019", "event_date_initiated": "2018-11-08", "event_date_created": "2018-12-21", "recall_status": "Terminated", "event_date_terminated": "2021-07-23", "res_event_number": "81649", "product_code": "IXY", "product_description": "Bucky Stand SU-4000 Input 2017.11.17.\nSU41711085\nDate: 2017-11-17; Board Name; Board Version, Firmware Version\n\nAdvanced Universal U-Arm 4000 System.\nThe Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable\nheight, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly.\nThe Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.", "code_info": "SU4000 AU 4000 U ARM Item Number DR-4000-MTB  Serials Numbers/Lot Numbers: SU41607003; SU41607004; SU41607005; SU41607006; SU41607008; SU41607009; SU41607010; SU41607011; SU41612012; SU41612013; SU41612014; SU41612015; SU41612016; SU41612017; SU41612018; SU41612019; SU41612020; SU41612021; SU41702006; SU41702007; SU41702009; SU41703010; SU41703011; SU41703012; SU41703013; SU41703015; SU41704016; SU41704017; SU41704019; SU41704020; SU41704021; SU41704022; SU41704023; SU41704024; SU41704025; SU41705026; SU41705027; SU41705028; SU41705029; SU41705031; SU41705032; SU41705033; SU41705034; SU41705035; SU41707036; SU41707038; SU41707039; SU41707040; SU41707041; SU41707042; SU41707043; SU41707044; SU41708046; SU41708047; SU41708048; SU41708049; SU41708050; SU41708051; SU41708052; SU41708053; SU41708054; SU41708055; SU41709060; SU41709061; SU41709062; SU41709063; SU41709064; SU41709065; SU41709066; SU41709068; SU41709069; SU41711070; SU41711071; SU41711072; SU41711073; SU41711074; SU41711075; SU41711076; SU41711077; SU41711079; SU41711080; SU41711081; SU41711082; SU41711083; SU41711084; SU41711085; SU41711086; SU41711087; SU41711088; SU41711089; SU41712090; SU41712093; SU41712094; SU41712095; SU41712096; SU41712097; SU41712098; SU41712099; SU4172091; SU41801001; SU41801002; SU41801003; SU41801004; SU41801005; SU41802006; SU41802007; SU41802008; SU41802009; SU41802010; SU41802011; SU41802012; SU41802013; SU41802014; SU41802015; SU41802016; SU41802017; SU41802018; SU41802019; SU41802020; SU41803021; SU41803022; SU41803023; SU41803024; SU41803025; SU41803026; SU41803028; SU41803029; SU41803030; SU41803031; SU41803032; SU41803033; SU41803034; SU41803035; SU41803037; SU41803038; SU41803039; SU41803040; SU41806041; SU41806042; SU41806043; SU41806044; SU41808047; SU41808048; SU41808049; SU41808050; SU41808053; SU41808054; SU41808055; SU41808058; SU41808060; SU41808063; SU41808064", "firm_fei_number": "3002885429", "recalling_firm": "Konica Minolta Healthcare, Americas, Inc.", "address_1": "2217 US Highway 70 E", "city": "Garner", "state": "NC", "postal_code": "27529-9424", "additional_info_contact": "Konica Minolta Customer Care Team\n800-945-0456", "reason_for_recall": "Unintentional U-Arm movement", "root_cause_description": "Device Design", "action": "On 11/08/2018, the firm send a letter titled;\" IMPORTANT PRODUCT INFORMATION\", regarding the Konica Minolta KDR U-Arm. Potential unintentional U-Arm movement due to the tablet enclosure buttons, located on the tablet enclosure, remaining engaged after being depressed.\n\nThe firm included a document titled, KDR U-ARM Tablet Enclosure FAQ as part of the IMPORTANT PRODUCT INFORMATION. The firm is preparing to issue an Interim Corrective Action; Disabling the buttons contained on the KDR tablet enclosure and a Final Corrective Action; A modification to the mounting of the PCB - which contains the drive buttons will reduce the potential of the event -this will help assure the buttons make the proper contact without staying depressed.\n\nIn addition, the firm issued a \"Technical Bulletin-Business Partner for the Product: KDR U-Arm Tablet Enclosure.\" The preliminary notification was sent to dealer partners which require all Partners to take immediate action.\nThere are two critical actions needed to mitigate this risk:\n\n1.\tInterim Action (Immediate Action Required):\nThe firm has released an immediate field corrective action to temporarily disconnect the tablet enclosure buttons. Instructions can be found in KON-000127 .\n\n2.\tFinal Action (Anticipated Release January 2019):\nA modification to the tablet design will help ensure the buttons make the proper contact without staying depressed.\n\nThe Interim Action/Field Correction is required to be completed by December 15, 2018.\n \n\nContact Konica Minolta Dispatch department at 1- 800-945-0456 to schedule a Konica Minolta Engineer to complete Corrective action. For each affected unit, it is important that your engineer performs the following:\n\n1. Complete the Tablet Button Disconnection procedure - KON-000127\n2.\tFill out form KON-000157 (Customer Signature required)\n3.\tTake a picture of the completed form KON-000157 and email to ServiceBilling@gcp.konicaminolta .com.", "product_quantity": "151", "distribution_pattern": "US Nationwide Distribution: AL; CA; CO; FL; GA; IA; IL; IN; KY; LA; MA; MI; MN; MO; NC; NH; NY; OH; OK; PA; SC; TN; TX; and VA.", "openfda": { "k_number": [ "K872132", "K895034", "K946114", "K891395", "K930249", "K790742", "K862828", "K924445", "K953336", "K853756", "K946260", "K791916", "K953402", "K810194", "K860454", "K915667", "K925934", "K922443", "K930230", "K850125", "K851440" ], "registration_number": [ "3014209556", "3005920099", "3005778458", "3005172103", "1724615", "3003768251", "3000126629", "9613445", "1418964", "3006551157", "3003102481", "2243057", "3003202425", "1450835", "3001556265", "3014403439", "9616014", "3010656982", "9710585", "1450503", "2431224", "3008284470", "3015276580", "3004756607", "3002466018", "9610903", "3013677815", "9617251", "8030233", "3029916061", "2436865", "3008141750" ], "fei_number": [ "3002808139", "3014209556", "3005920099", "3002175190", "3005778458", "3005172103", "3003768251", "3000126629", "1000521490", "3002495042", "1418964", "3006551157", "3003102481", "3002807145", "2243057", "3003202425", "1450835", "3001556265", "3014403439", "1000396729", "3010656982", "1450503", "3002675731", "2431224", "3008284470", "3015276580", "3004756607", "3002466018", "3013677815", "3001620005", "3029916061", "3008141750" ], "device_name": "Holder, Radiographic Cassette, Wall-Mounted", "medical_specialty_description": "Radiology", "regulation_number": "892.1880", "device_class": "1" } } ] }