{ "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": "158982", "product_res_number": "Z-0517-2018", "event_date_initiated": "2017-07-14", "event_date_posted": "2018-01-09", "recall_status": "Terminated", "event_date_terminated": "2018-07-23", "res_event_number": "78105", "product_code": "EHD", "k_numbers": [ "K870236", "K882436" ], "product_description": "PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3", "code_info": "Serial Numbers: 6001 to 19340", "firm_fei_number": "1832462", "recalling_firm": "Panoramic Rental Corp.", "address_1": "4321 Goshen Rd", "city": "Fort Wayne", "state": "IN", "postal_code": "46818-1201", "reason_for_recall": "The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.", "root_cause_description": "Device Design", "action": "On July 14, 2017, Panoramic distributed Urgent Medical Device Correction notices to customers who own and have not taken action as required for the PC-1000 X-ray system machines. This means that your device does not have a critical safety feature that is intended to protect your patients and staff from harm. Customers are encouraged to immediately discontinue use of their machine and follow the instructions in the notice. Customers are encouraged to not resume use of the machine until a certified Panoramic service technician repairs the lift motor. Customers are advised to contact Panoramic to ensure any safety risks associated with the lift motor are identified and addressed. \n\nAction Required:\n(A) If your PC1000 machine is still in service at this location, you must immediately discontinue use and choose one of the following by returning the Acknowledgement Form or contacting the Panoramic Service Team by calling 888-381-2577 Monday through Friday 8 am - 6 pm.\n1. An upgraded lift motor assembly at no cost to you;\n2. A digital Panoramic rental unit to replace your PC1000, contingent on a signed one year rental contract (subject to availability); or\n3. A new digital Panoramic or PanoramicCephalometric unit to replace your PC1000 at a reduced price (starting\nat $17,995 depending on machine type and subject to availability)\n(B) If your PC1000 machine is no longer in service or under your control:\n4. If the machine is no longer in service, Panoramic will provide free removal of your machine.", "product_quantity": "13,340 units", "distribution_pattern": "US Nationwide distribution including Puerto Rico", "openfda": { "k_number": [ "K934063", "K190935", "K002062", "K043557", "K001248", "K925094", "K031118", "K013176", "K923360", "K043307", "K141293", "K181891", "K970975", "K252909", "K972168", "K970850", "K961826", "K220574", "K872240", "K972968", "K211014", "K080076", "K020070", "K000428", "K980543", "K932111", "K063121", "K963403", "K970812", "K213282", "K935046", "K781288", "K190357", "K122124", "K040748", "K051464", "K132041", "K000672", "K092103", "K874238", "K931300", "K033073", "K972921", "K223058", "K241305", "K043612", "K984030", "K233914", "K021378", "K051795", "K172810", "K180561", "K895467", "K221233", "K223780", "K974077", "K141497", "K232085", "K232068", "K163705", "K201800", "K240759", "K033690", "K060640", "K242591", "K024285", "K022630", "K962120", "K180671", "K060292", "K161063", "K031802", "K984524", "K011619", "K031448", "K030634", "K962337", "K894935", "K093240", "K082875", "K163519", "K132378", "K000061", "K964659", "K974877", "K043104", "K231449", "K032355", "K952763", "K170967", "K955429", "K160458", "K000771", "K875212", "K980581", "K152859", "K930338", "K870236", "K972249", "K860835", "K233395", "K130109", "K090749", "K962631", "K222274", "K083344", "K123493", "K000163", "K260367", "K994285", "K092772", "K772164", "K991912", "K012355", "K093105", "K043092", "K222569", "K033755", "K965203", "K103600", "K000551", "K811103", "K082167", "K864474", "K081899", "K232012", "K042260", "K970263", "K973476", "K882436", "K923067", "K792581", "K001729", "K200182", "K254018", "K002432", "K973642", "K252110", "K103579", "K173319", "K991310", "K963185", "K931001", "K172928", "K972312", "K780469", "K111330", "K122016", "K040382", "K871051", "K011147", "K963699", "K221587", "K030647", "K253864", "K251438", "K854741", "K912893", "K050255", "K851095", "K091255", "K992610", "K241963", "K223010", "K926575", "K781286", "K091197", "K231055", "K030185", "K122582", "K913652", "K081664", "K192700", "K991518", "K872825", "K800133", "K965072", "K962422", "K931725", "K242185", "K021245", "K043136", "K013955", "K221286", "K182206", "K924130", "K991455", "K050019", "K220579", "K040556" ], "registration_number": [ "3010446656", "3003934980", "3014209556", "3043564919", "3008252267", "3006610845", "9615832", "3011491794", "1226003", "3006540014", "9614977", "3005383085", "3015376465", "1526534", "3009608361", "3045366281", "2024949", "3015153900", "3005172103", "3005246977", "3013779985", "3005843418", "3013511605", "3014398772", "9611445", "3009001657", "1523530", "3013099020", "9615782", "3010972172", "3003528079", "3015502499", "3023546785", "3004884150", "3045816948", "3016075921", "2424472", "3008361230", "3007933232", "8043962", "3012187973", "3016875543", "3004706313", "3021551875", "1419489", "3008770655", "3005581016", "8030876", "3031886796", "2024980", "8020825", "3012649815", "3025308469", "3002819275", "3029916103", "3002994636", "3014980469", "3009134655", "3022107311", "1423662", "1054713", "8044167", "3023861999" ], "fei_number": [ "3010446656", "3003934980", "3014209556", "3043564919", "3008252267", "3006610845", "3011491794", "3015376465", "3006540014", "3005383085", "3003719498", "1526534", "3009608361", "1000114111", "3003026827", "3045366281", "2024949", "3002522649", "3015153900", "3002808310", "3005172103", "3002088145", "3005246977", "3013779985", "3005843418", "3013511605", "3014398772", "3004084693", "3009001657", "1523530", "3013099020", "3008875470", "3000215273", "3010972172", "3003528079", "3015502499", "3023546785", "3004884150", "3045816948", "3016075921", "3008361230", "3007933232", "3012187973", "3016875543", "3004706313", "3021551875", "1419489", "3008770655", "3005581016", "3031886796", "3012649815", "3025308469", "7695", "3002819275", "3029916103", "3002994636", "3014980469", "3009134655", "1000207287", "3002772487", "3022107311", "3002948158", "3023861999" ], "device_name": "Unit, X-Ray, Extraoral With Timer", "medical_specialty_description": "Dental", "regulation_number": "872.1800", "device_class": "2" } } ] }