{ "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": "122704", "product_res_number": "Z-0651-2014", "event_date_initiated": "2013-09-20", "event_date_posted": "2014-01-09", "recall_status": "Terminated", "event_date_terminated": "2017-12-27", "res_event_number": "66603", "product_code": "MUH", "k_numbers": [ "K122643" ], "product_description": "The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800", "code_info": "Vantage Panoramic X-Ray System firmware versions: 3.0, 3.1, 3.2, and 3.3.   Vantage Panoramic X-Ray System Catalog Numbers and Serial Numbers: Catalog Number V5000, Serial Numbers ZM81025, ZM81026, ZM81030, ZZ08005, ZZ08006, ZZ08007, ZZ08008, ZZ08009, ZZ08010, ZZ08011, ZZ08012, ZZ08013, ZZ08015, ZZ08016, ZZ08017, Z08018, ZZ08019, ZZ08020, ZZ08021, ZZ08022, ZZ08023, ZB51001, ZB51002, ZB51006, ZB51007, ZT18018, ZY49014, ZK58019, ZS54011, ZP01043, ZV78016, ZE09006, ZN44018, ZS59007, ZS59001, ZW15007, ZW34003, ZW34012, ZW34018, ZY49012, ZY49015, ZZ02010, ZM81022, ZS54012, ZE09019, ZM81017, ZT18004, ZT18015, ZN44020, ZE09012, ZM81023, ZT27012;  Catalog Number V5050, Serial Number ZZ08014;  Catalog Number V5100, Serial Numbers ZM81027, ZM81028, ZZ08003; Catalog Number V5150, Serial Number ZZ08002;  Catalog Number V5150C, Serial Number ZM81016", "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": "Mr. Anthony Bavuso\n847-850-3800", "reason_for_recall": "An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. failure to stop\").", "root_cause_description": "Software design", "action": "An URGENT MEDICAL DEVICE FIELD CORRECTION letter dated September 20, 2013 was sent to all consignees. \n\nLetters sent to distributors include instructions on how to identify the defective units, to quarantine the machine(s), and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will either schedule an on-site field correction or arrange for the replacement of the affected device(s) depending on the customer's preference. Midmark further requested the distributors provide Midmark with the names, addresses, phone numbers, and e-mail addresses of any customers that purchased any defective units. \n\nField corrections include the upgrading of RTC firmware to revision 3.4 on the defective units and will be performed as no additional charge by Midmark personnel. \n\nLetter sent to practitioners include instructions on how to identify the defective units, instructions on how to temporarily reduce the likelihood of the unintentional movement, and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will schedule an on-site field correction by upgrading the firmware to revision 3.4.", "product_quantity": "58 units", "distribution_pattern": "Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, CA, CO, CT, FL, GA, IL, KS, MA, NC, NH, NJ, OH, OK, PA, SC, TN, TX, VA, and WI, and the countries of Australia, Canada, and Russia.", "openfda": { "k_number": [ "K081903", "K150797", "K212279", "K070664", "K001928", "K230732", "K163282", "K993958", "K143703", "K230916", "K231202", "K101661", "K073696", "K232255", "K992644", "K023346", "K110768", "K093590", "K181636", "K220556", "K033248", "K063837", "K162585", "K192766", "K990528", "K161131", "K232325", "K053220", "K163175", "K212080", "K242778", "K120263", "K111649", "K013271", "K202633", "K013650", "K012170", "K060079", "K093683", "K120975", "K070219", "K130419", "K050693", "K141130", "K122643", "K073365", "K181297", "K041831", "K070811", "K053221", "K151087", "K221008", "K024186", "K133231", "K112380", "K092537", "K111103", "K983267", "K090458", "K200284", "K170733", "K053172", "K153144", "K110371", "K181358", "K213637", "K143753", "K100317", "K122155", "K012514", "K061284", "K083532", "K091866", "K023292", "K172918", "K220422", "K041834", "K251793", "K022953", "K990087", "K230998", "K221955", "K212103", "K190234", "K230811", "K150823", "K191623", "K111231", "K163224", "K992392", "K251206", "K120318", "K081925", "K090526", "K214091", "K070505", "K110160", "K141700", "K983057", "K060328", "K042372", "K173046", "K241649", "K130088", "K060149", "K103290", "K133007", "K210312", "K151053", "K151707", "K031801", "K062403", "K142058", "K002425", "K203116", "K033147", "K092591", "K200625", "K021542", "K151926", "K232158", "K020588", "K073435", "K121800", "K252570", "K183637", "K230095", "K092171", "K103689", "K102456", "K013893", "K072244", "K053558", "K072134", "K170731", "K202369", "K983283", "K113497", "K202664", "K013659", "K041120", "K083057", "K102124", "K080889", "K060178", "K250687", "K992385", "K001439", "K142995", "K173646", "K060892", "K990002", "K041050", "K070535", "K131693", "K062529", "K051664", "K100960", "K010915", "K133206", "K021718", "K211317", "K082972", "K090020", "K081088", "K042736", "K073350", "K233053", "K191719", "K231660", "K152162", "K130585", "K182198", "K060179", "K093478", "K092329", "K131442", "K133271", "K160386", "K160788", "K041580", "K092547", "K122806", "K240040", "K072357", "K063459", "K220423", "K123419", "K070304", "K990049", "K162190", "K211688", "K220277", "K000454", "K134055", "K120106", "K061114", "K113672", "K031291", "K153060", "K111152", "K140013", "K203374", "K162619", "K232552", "K122918" ], "registration_number": [ "3010281549", "3034604691", "3009608361", "3020117925", "3013779985", "3012421607", "3043226252", "3016875543", "3004706313", "3014683120", "3012649815", "3044819802", "3010476612", "3007007357", "3045855232", "3010609444", "3011471624", "1054713", "3002807636", "3015464948", "3008252267", "3006610845", "1226003", "2024949", "3018999255", "3005843418", "3009598746", "3014398772", "1523530", "9615782", "3003528079", "2424472", "8043962", "1032227", "3008770655", "8020825", "1725006", "3013503781", "3003314115", "3042046320", "3013651568", "3012494290", "3014544225", "8044167", "3023861999", "3003934980", "9615832", "3006540014", "3005383085", "3005972890", "3008313821", "9611445", "3010972172", "3010445368", "3015509619", "3008361230", "3012187973", "3021551875", "3009196578", "3025442726", "3005581016", "9611036", "3029916103", "3002994636", "3013186032", "3009048384", "2032641", "3000190675", "3017403245", "3038718579", "3045129740", "3021736604", "3015376465", "3007065358", "3001052305", "3013511605", "3030126955", "3031823608", "3004105475", "3013039893", "3013360312", "8030876", "2024980", "3007538876", "3002819275", "3009532935", "2428225", "3004765453", "3022107311", "3007515144" ], "fei_number": [ "3010281549", "3034604691", "3009608361", "3020117925", "3002522649", "3002088145", "3013779985", "3012421607", "3043226252", "3016875543", "3004706313", "3014683120", "3012649815", "3044819802", "3010476612", "3007007357", "3045855232", "1000207287", "3010609444", "3002772487", "3011471624", "3002807636", "3015464948", "3008252267", "3006610845", "2024949", "3018999255", "3005843418", "3009598746", "3014398772", "1523530", "3003528079", "1032227", "3008770655", "3013503781", "3003314115", "3042046320", "3013651568", "3012494290", "3014544225", "3023861999", "3003934980", "3006540014", "3005383085", "1000114111", "3005972890", "3003026827", "3002808310", "3008313821", "3004084693", "3008875470", "3010972172", "3010445368", "3015509619", "3008361230", "3012187973", "3021551875", "3009196578", "3025442726", "3005581016", "3003258642", "7695", "3029916103", "3002994636", "3013186032", "3009048384", "3000190675", "3002948158", "3017403245", "3038718579", "3045129740", "3003888257", "3021736604", "3015376465", "3007065358", "3001052305", "3013511605", "3030126955", "3031823608", "3004105475", "3013039893", "3002809599", "3013360312", "3007538876", "3002819275", "3009532935", "2428225", "3004765453", "3022107311", "3007515144" ], "device_name": "System, X-Ray, Extraoral Source, Digital", "medical_specialty_description": "Dental", "regulation_number": "872.1800", "device_class": "2" } } ] }