{ "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": "113697", "product_res_number": "Z-0118-2013", "event_date_initiated": "2012-08-21", "event_date_posted": "2012-10-23", "recall_status": "Terminated", "event_date_terminated": "2014-11-03", "res_event_number": "63405", "product_code": "MUJ", "k_numbers": [ "K081281" ], "product_description": "Oncentra External Beam 4.1.\n\nRadiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.", "code_info": "None as the product is software", "firm_fei_number": "1037831", "recalling_firm": "Elekta, Inc.", "address_1": "4775 Peachtree Industrial Blvd", "address_2": "Bldg 300 #300", "city": "Norcross", "state": "GA", "postal_code": "30092-3011", "additional_info_contact": "Thomas Valentine\n770-300-9725", "reason_for_recall": "During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.", "root_cause_description": "Software design", "action": "Nucletron sent a Customer Information Bulletin 555.00248 to all affected customers. The bulletin identified the product, problem, and actions to be taken by the customers. The bulletin contained information on how an incorrect dose association can be prevented by not renumbering beams during recalculation. A Read Confirmation Form was included for customers to complete and return. Contact your local Nucleton Service Representative for questions regarding this notice.", "product_quantity": "52 units", "distribution_pattern": "Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA.", "openfda": { "k_number": [ "K132971", "K091179", "K982696", "K915691", "K211379", "K232400", "K171885", "K201444", "K982791", "K252304", "K012017", "K242992", "K211034", "K142108", "K041403", "K011246", "K041719", "K100056", "K160093", "K983343", "K180379", "K123263", "K051497", "K022036", "K991815", "K211841", "K260308", "K042269", "K100417", "K220783", "K082221", "K051941", "K100552", "K002312", "K201607", "K223279", "K151666", "K032724", "K210645", "K984532", "K150547", "K993675", "K133331", "K112723", "K081281", "K013112", "K211511", "K253078", "K994413", "K202789", "K013673", "K992762", "K090972", "K240671", "K182665", "K083264", "K133247", "K041971", "K192065", "K010682", "K022411", "K090531", "K151560", "K170086", "K090182", "K151887", "K002147", "K172163", "K252109", "K203469", "K032345", "K190664", "K063482", "K002509", "K080888", "K133655", "K111311", "K151380", "K213438", "K162370", "K220582", "K101076", "K991237", "K061097", "K200569", "K213787", "K250963", "K091146", "K193109", "K974770", "K042739", "K202284", "K092132", "K112060", "K081112", "K141283", "K091492", "K113102", "K022307", "K102216", "K042861", "K063230", "K020027", "K170750", "K061440", "K120363", "K200608", "K220141", "K241318", "K012575", "K123152", "K242748", "K232799", "K252002", "K022741", "K031349", "K062967", "K121448", "K152393", "K141860", "K173940", "K992864", "K013644", "K222312", "K100092", "K203766", "K242378", "K193640", "K252863", "K243057", "K222803", "K990475", "K032456", "K040474", "K253050", "K993766", "K140187", "K161136", "K131891", "K141900", "K200487", "K050296", "K103093", "K071938", "K082005", "K083414", "K203681", "K001295", "K993923", "K182888", "K021268", "K123357", "K993895", "K151435", "K151369", "K233236", "K093588", "K092928", "K101220", "K080601", "K141248", "K214081", "K240398", "K013661", "K061893", "K211881", "K211867", "K990071", "K071760", "K002132", "K242822", "K143514", "K120387", "K250064", "K082642", "K223724", "K231825", "K222728", "K992434", "K170969", "K001700", "K062514", "K153368", "K982821", "K080929", "K071873", "K151469", "K031088", "K260207", "K053584", "K010784", "K191384", "K992753", "K093391", "K170355", "K030821", "K041997", "K130617", "K151233", "K192554", "K252784", "K132816", "K131428", "K013535", "K171536", "K031281", "K083672", "K110730", "K002237", "K103246", "K040688", "K193381", "K103146", "K082606", "K190178", "K052325", "K223233", "K260750", "K984196", "K212274", "K020971", "K022961", "K032209", "K181145", "K102915", "K981678", "K183037", "K230557", "K992303", "K112446", "K120551", "K201350", "K241876", "K102011", "K143269", "K090808", "K190387", "K002240", "K112776", "K234068", "K250440", "K180308", "K232479", "K083502", "K090893", "K000922", "K242463", "K091145", "K173635", "K101119", "K103515", "K073020", "K180289", "K062032", "K253091", "K193459", "K152488" ], "registration_number": [ "1038814", "2030598", "8043933", "3019834893", "3012039133", "3014425747", "3016686005", "3003873069", "3009529630", "2183553", "3004555507", "3011716550", "3025309924", "3003418325", "3000126629", "3007791541", "9617978", "3044735888", "1651102", "3002808157", "3008156050", "3003586672", "3003793371", "3009090417", "3004363352", "3005136058", "3014873236", "3025765259", "3006579682", "3019543601", "3006894636", "3015777306", "3004561814", "3010034862", "3013410552", "3009302839", "9611894", "3010123525", "3003094912", "3007037519", "3004580128", "3022719374", "2916710", "3022745617", "3018004899", "3004608878", "2939248", "3004977335", "3030564015", "3007774465", "3009077524", "3016602874", "3042177665", "3015232217", "3023344262", "3033527281", "2434141", "3003768277", "3004526608" ], "fei_number": [ "1038814", "3019834893", "3012039133", "3014425747", "3016686005", "3003873069", "3002619595", "3009529630", "2183553", "3004555507", "3011716550", "3025309924", "3003418325", "3000126629", "3007791541", "3044735888", "3002807741", "3002808157", "3008156050", "3003586672", "3003793371", "3009090417", "3004363352", "3005136058", "3014873236", "3002807880", "3025765259", "3006579682", "3019543601", "3006894636", "3015777306", "3002802883", "3004561814", "3010034862", "3013410552", "3009302839", "3003094912", "3010123525", "3007037519", "3004580128", "3022719374", "2916710", "3022745617", "3018004899", "3004608878", "2939248", "3004977335", "3030564015", "3007774465", "1000518731", "3009077524", "3016602874", "3008581796", "3042177665", "3015232217", "3023344262", "3033527281", "2434141", "3004526608" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }