{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "134633", "product_res_number": "Z-0651-2016", "event_date_initiated": "2014-09-04", "event_date_created": "2016-01-25", "recall_status": "Terminated", "event_date_terminated": "2017-12-29", "res_event_number": "70765", "product_code": "MUH", "k_numbers": [ "K122643" ], "product_description": "Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging\n\nThe Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu", "code_info": "Model Number: 60-A0001; 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"firm_fei_number": "3000210017", "recalling_firm": "Midmark Corp dba Progeny Inc", "address_1": "675 Heathrow Dr", "city": "Lincolnshire", "state": "IL", "postal_code": "60069-4206", "additional_info_contact": "Midmark Technical Support\n888-924-3800 Ext. 3", "reason_for_recall": "Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.", "root_cause_description": "Device Design", "action": "MidMark sent an Urgent Medical Device Field Correction letter dated September 4, 2014, to all affected customers. The letter included instructions for distributors to: 1) encourage end users to contact Midmark to arrange the field correction after the final solution becomes available; 2) if a partial image is reported to have occurred with a machine, the machine should be removed from use and the end user should initiate a service request per the normal procedure; 3) quarantine any affected machines in the distributor's inventory and contact Midmark Technical Support within 10 business days to provide the Serial numbers to on-site servicing of the affected machines can be scheduled. Distributors with questions about this market action can contact Midmark Technical Support by calling 888-294-3800 x 3 or by e-mail at imagingtechnsupport@midmark.com.", "product_quantity": "832 systems", "distribution_pattern": "Worldwide Distribution - US including AL, AR, AZ, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI; and Internationally to Australia, Belgium, Canada, Czech Republic, France, Hungary, Lithuania, New Zealand, Poland, Russia, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K010915", "K190234", "K230811", "K050693", "K173646", "K232158", "K073696", "K192766", "K041120", "K092547", "K112380", "K133007", "K203116", "K090458", "K091866", "K060892", "K220422", "K123419", "K100317", "K172918", "K252570", "K162190", "K141700", "K202369", "K251206", "K203374", "K070304", "K241649", "K212080", "K090526", "K233053", 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"K060178", "K153060", "K070535", "K150797", "K182198", "K021718", "K133231", "K211688", "K181636", "K093478", "K142995", "K141130", "K232255", "K120975", "K031291", "K063837", "K213637", "K173046", "K230732", "K231202", "K131442", "K152162", "K020588", "K211317", "K013650", "K002425", "K990002", "K151087", "K022953", "K060328", "K151053", "K060079", "K111649", "K070219", "K083057", "K202633", "K102456", "K212279", "K031801", "K092329", "K983283", "K160788", "K041831", "K202664", "K110371", "K083532", "K220423", "K062529", "K041834", "K041050", "K221008", "K230916", "K983057", "K060149", "K120106", "K983267", "K231660", "K092591", "K191719", "K051664", "K100960", "K121800", "K111152", "K181297", "K163282", "K073435", "K103290", "K061114", "K200284", "K992644", "K214091", "K122643", "K150823", "K072244", "K120263", "K251793", "K113497", "K133271", "K122155", "K062403", "K130585", "K110768", "K992392", "K990528" ], "registration_number": [ "3001052305", "3018999255", "3014544225", 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"1032227", "3011471624", "3013651568", "3010445368", "3013779985", "3007065358", "1725006", "3005383085", "3013511605", "8044167", "3010972172", "3042046320", "3030126955" ], "fei_number": [ "3001052305", "3018999255", "3014544225", "3005581016", "3008361230", "3014683120", "3015376465", "3013360312", "3031823608", "2428225", "3002994636", "3007515144", "3002819275", "3006540014", "3002809599", "3012649815", "3008252267", "3010476612", "1000207287", "3044819802", "3005972890", "1000114111", "3002807636", "3029916103", "3009048384", "3015464948", "2024949", "3012187973", "3014398772", "3004706313", "3022107311", "3043226252", "3007007357", "3002808310", "3002522649", "3002088145", "3006610845", "1523530", "3025442726", "3000190675", "3010281549", "3015509619", "3013186032", "3004105475", "3008770655", "3003528079", "3009608361", "3016875543", "3003258642", "3003314115", "3012494290", "3003888257", "3012421607", "3013039893", "3021736604", "3008875470", "3023861999", "3005843418", "3045129740", "3004765453", "3003934980", "3034604691", "3009196578", "3009598746", "3010609444", "3002772487", "3038718579", "3045855232", "3013503781", "3020117925", "7695", "3021551875", "3003026827", "3017403245", "3008313821", "3009532935", "3007538876", "1032227", "3002948158", "3011471624", "3013651568", "3010445368", "3013779985", "3007065358", "3004084693", "3013511605", "3005383085", "3010972172", "3042046320", "3030126955" ], "device_name": "System, X-Ray, Extraoral Source, Digital", "medical_specialty_description": "Dental", "regulation_number": "872.1800", "device_class": "2" } } ] }