{ "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": 18 } }, "results": [ { "cfres_id": "129485", "product_res_number": "Z-0009-2015", "event_date_initiated": "2014-08-12", "event_date_posted": "2014-10-02", "recall_status": "Terminated", "event_date_terminated": "2017-03-24", "res_event_number": "69064", "product_code": "EHD", "k_numbers": [ "K992610" ], "product_description": "eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly\nw/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm\n& Tubehead, 765DC\n\nProduct Usage: intraoral x-ray", "code_info": "Models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC; with multiple part numbers and serial numbers: see distribution list for these details.", "firm_fei_number": "3009212242", "recalling_firm": "Gendex Corp", "address_1": "2800 Crystal Dr", "city": "Hatfield", "state": "PA", "postal_code": "19440-1944", "additional_info_contact": "Customer Support\n267-954-1463", "reason_for_recall": "Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.", "root_cause_description": "Nonconforming Material/Component", "action": "Gendex sent a Recall Notification Letter, dated August 12, 2014 and a second Communication Notification letter on September 22, 2014 to all affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Gendex Customer Service at 1-800-323-8029.", "product_quantity": "651", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.", "openfda": { "k_number": [ "K103600", "K952763", "K201800", "K260367", "K081664", "K043612", "K001729", "K170967", "K780469", "K231055", "K240759", "K132041", "K962337", "K984030", "K000163", "K122124", "K090749", "K063121", "K860835", "K093240", "K930338", "K060640", "K022630", "K963403", "K021378", "K972168", "K043092", "K001248", "K200182", "K081899", "K083344", "K002432", "K220579", "K013955", "K221286", "K963185", "K251438", "K254018", "K912893", "K962631", "K961826", "K050255", "K182206", "K181891", "K091197", "K874238", "K040748", "K161063", "K190935", "K924130", "K012355", "K152859", "K965072", "K051795", "K991310", "K180561", "K781286", "K082167", "K011619", "K972968", "K970975", "K972249", "K935046", "K233395", "K955429", "K991912", "K223780", "K864474", "K970850", "K000672", "K141293", "K223058", "K040382", "K972921", "K111330", "K013176", "K122582", "K974077", "K992610", "K980543", "K080076", "K050019", "K002062", "K132378", "K130109", "K000771", "K882436", "K894935", "K870236", "K923360", "K972312", "K926575", "K103579", "K962422", "K221233", "K854741", "K091255", "K123493", "K964659", "K875212", "K030185", "K980581", "K991518", "K222274", "K042260", "K043557", "K192700", "K040556", "K180671", "K031802", "K160458", "K232012", "K811103", "K242591", "K011147", "K994285", "K221587", "K092772", "K931300", "K172928", "K213282", "K033755", "K925094", "K030647", "K043104", "K122016", "K800133", "K033073", "K991455", "K792581", "K934063", "K033690", "K220574", "K913652", "K032355", "K043307", "K962120", "K173319", "K241305", "K020070", "K093105", "K000428", "K031118", "K231449", "K253864", "K772164", "K965203", "K233914", "K232068", "K895467", "K781288", "K984524", "K030634", "K031448", "K241963", "K923067", "K163519", "K000551", "K970812", "K872825", "K973642", "K242185", "K974877", "K851095", "K163705", "K211014", "K232085", "K973476", "K963699", "K252909", "K051464", "K931725", "K000061", "K252110", "K970263", "K932111", "K931001", "K172810", "K043136", "K082875", "K024285", "K092103", "K190357", "K141497", "K021245", "K871051", "K872240", "K060292", "K223010", "K222569" ], "registration_number": [ "3005843418", "9611445", "3012187973", "1523530", "3009001657", "3002819275", "3023861999", "3004706313", "1526534", "3013511605", "3015153900", "3008770655", "3005246977", "3013099020", "3021551875", "9614977", "3016075921", "3016875543", "3022107311", "1226003", "3031886796", "3045816948", "2424472", "3006540014", "3011491794", "3015376465", "8020825", "3005581016", "8030876", "3009134655", "3015502499", "3002994636", "3023546785", "3045366281", "1423662", "3007933232", "2024949", "9615782", "3012649815", "3010972172", "3003934980", "8043962", "3010446656", "1054713", "9615832", "3014209556", "3003528079", "3005172103", "3008361230", "3004884150", "3043564919", "3008252267", "3025308469", "3013779985", "3014398772", "3005383085", "8044167", "3006610845", "3009608361", "2024980", "3014980469", "3029916103", "1419489" ], "fei_number": [ "3005843418", "3012187973", "1523530", "3009001657", "3002819275", "3002948158", "3023861999", "3004706313", "1526534", "3013511605", "3002522649", "3015153900", "3008770655", "3005246977", "3013099020", "3021551875", "3016075921", "3016875543", "3022107311", "3031886796", "3008875470", "3045816948", "3006540014", "3011491794", "3015376465", "3005581016", "3009134655", "3015502499", "3002994636", "3023546785", "3045366281", "3003719498", "3002808310", "3007933232", "2024949", "3012649815", "3010972172", "3003934980", "3010446656", "7695", "3000215273", "3014209556", "3003528079", "3005172103", "3008361230", "3004884150", "3043564919", "3008252267", "3025308469", "3002772487", "3004084693", "3013779985", "3014398772", "3002088145", "3014980469", "3005383085", "3006610845", "3009608361", "1000114111", "1000207287", "3003026827", "3029916103", "1419489" ], "device_name": "Unit, X-Ray, Extraoral With Timer", "medical_specialty_description": "Dental", "regulation_number": "872.1800", "device_class": "2" } } ] }