{ "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": 267 } }, "results": [ { "cfres_id": "104054", "product_res_number": "Z-0014-2012", "event_date_initiated": "2011-05-25", "event_date_created": "2015-06-26", "recall_status": "Terminated", "event_date_terminated": "2014-01-14", "res_event_number": "59949", "product_code": "MUJ", "k_numbers": [ "K001163" ], "product_description": "Dynamic Multileaf Collimator (DMLC)\r\n\r\nShapes the radiation beam in treatment therapy.", "code_info": "116001, 116012, 116044, EM7-008, 116055, 116064, 116014, 116052, 116023, 116056, 116053, 116047, 116043, 116051, 116070, 116122, 116063, 116020, EM7-003, EM-029, EM7-006, 116024, 116068, 116013, EM3-026, EM3-004, 116046", "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\n770-670-2548", "reason_for_recall": "It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).", "root_cause_description": "Device Design", "action": "Elekta, Inc. sent an \"IMPORTANT NOTICE\" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter recommends several precautions customers should use until Elekta finds a solution. Customers will be contacted when a solution is found.", "product_quantity": "27", "distribution_pattern": "Nationwide Distribution-USA including the state of CT, FL, GA, IA, MN, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA , and WA.", "openfda": { "k_number": [ "K071873", "K180308", "K001295", "K161136", "K990475", "K031349", "K233236", "K013112", "K041997", "K112060", "K242992", "K993675", "K160093", "K181145", "K121448", "K130617", "K173940", "K172163", "K250963", "K090531", "K012017", "K203766", "K013535", "K062032", "K082221", "K152393", "K220582", "K080601", "K123152", "K002237", "K091179", "K201350", "K170355", "K090182", "K200487", "K123357", "K241318", "K252784", "K011246", "K992753", "K041719", "K021268", "K243057", "K093391", "K082606", "K132816", "K010784", "K201607", "K022741", "K083672", "K002147", "K212274", "K151369", "K032209", "K091492", "K061097", "K102011", "K190178", "K042269", "K041971", "K083502", "K211034", "K100552", "K223233", "K092928", "K062514", "K151233", "K151469", "K210645", "K022036", "K222728", "K223279", "K002509", "K090893", "K982821", "K990071", "K170086", "K211379", "K214081", "K192554", "K142108", "K071938", "K193109", "K112776", "K013661", "K983343", "K232479", "K041403", "K101076", "K100092", "K111311", "K080888", "K071760", "K123263", "K222312", "K230557", "K993895", "K051497", "K101220", "K223724", "K193640", "K252109", "K101119", "K171885", "K020027", "K992864", "K915691", "K080929", "K180379", "K982791", "K141283", "K182888", "K102216", "K020971", "K994413", "K131891", "K143514", "K151666", "K220141", "K182665", "K202284", "K211841", "K250064", "K082005", "K042861", "K132971", "K151380", "K211881", "K103246", "K040688", "K030821", "K240671", "K153368", "K002312", "K234068", "K260207", "K253091", "K211867", "K131428", "K242822", "K002240", "K252002", "K133655", "K993923", "K031281", "K083264", "K191384", "K091146", "K110730", "K143269", "K992434", "K231825", "K220783", "K982696", "K993766", "K252304", "K090808", "K063230", "K141860", "K112723", "K240398", "K050296", "K200569", "K253050", "K000922", "K241876", "K103146", "K133247", "K242748", "K040474", "K120363", "K053584", "K081112", "K193381", "K082642", "K171536", "K093588", "K051941", "K232799", "K250440", "K031088", "K013644", "K151887", "K252863", "K013673", "K032456", "K170750", "K203469", "K061893", "K061440", "K052325", "K100417", "K253078", "K232400", "K032724", "K152488", "K091145", "K151435", "K183037", "K112446", "K192065", "K022307", "K103093", "K083414", "K012575", "K974770", "K103515", "K073020", "K141248", "K981678", "K170969", "K002132", "K151560", "K201444", "K211511", "K063482", "K141900", "K190387", "K140187", "K260750", "K102915", "K180289", "K203681", "K150547", "K242378", "K992762", "K001700", "K991237", "K100056", "K133331", "K984532", "K092132", "K202789", "K173635", "K162370", "K242463", "K992303", "K190664", "K022411", "K984196", "K010682", "K120551", "K090972", "K120387", "K213438", "K032345", "K081281", "K113102", "K200608", "K222803", "K022961", "K991815", "K260308", "K062967", "K042739", "K193459", "K213787" ], "registration_number": [ "3010123525", "3004608878", "3011716550", "3030564015", "9617978", "3003094912", "3010034862", "3013410552", "3007791541", "3009077524", "3022745617", "3033527281", "1038814", "3003586672", "2183553", "3004977335", "3002808157", "3019834893", "3006579682", "3016602874", "3009302839", "3006894636", "3004580128", "2030598", "3014425747", "3016686005", "3007037519", "3004555507", "3025765259", "3025309924", "3003873069", "3004526608", "3019543601", "3003768277", "3042177665", "1651102", "9611894", "3018004899", "3044735888", "3003793371", "8043933", "3012039133", "3008156050", "3023344262", "3007774465", "2434141", "3015232217", "3015777306", "3009090417", "3022719374", "3000126629", "3003418325", "3004363352", "2939248", "3004561814", "3009529630", "3014873236", "3005136058", "2916710" ], "fei_number": [ "3010123525", "3004608878", "3011716550", "3030564015", "3003094912", "3010034862", "3013410552", "3007791541", "3009077524", "3022745617", "3033527281", "1038814", "3003586672", "2183553", "3004977335", "3002808157", "3019834893", "3006579682", "3016602874", "3009302839", "3006894636", "1000518731", "3014425747", "3004580128", "3016686005", "3007037519", "3004555507", "3025765259", "3025309924", "3003873069", "3004526608", "3019543601", "3042177665", "3002807880", "3002807741", "3018004899", "3044735888", "3003793371", "3012039133", "3008581796", "3008156050", "3023344262", "3002802883", "3007774465", "2434141", "3015232217", "3015777306", "3009090417", "3022719374", "3000126629", "3002619595", "3003418325", "3004363352", "2939248", "3004561814", "3009529630", "3014873236", "3005136058", "2916710" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }