{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "140993", "product_res_number": "Z-0181-2016", "event_date_initiated": "2015-10-16", "event_date_posted": "2015-10-30", "recall_status": "Terminated", "event_date_terminated": "2017-04-04", "res_event_number": "72424", "product_code": "MUJ", "k_numbers": [ "K151233" ], "product_description": "Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.", "code_info": "Software Version 5.10.01", "firm_fei_number": "1037831", "recalling_firm": "Elekta, Inc.", "address_1": "400 Perimeter Center Ter NE Ste 50 400 Perimeter Center Ter NE", "address_2": "Ste 50", "city": "Atlanta", "state": "GA", "postal_code": "30346-1227", "additional_info_contact": "Linda Wetsel\n770-300-9725", "reason_for_recall": "Unintended update of Dose and MU and Incorrect Assignment of Bolus.", "root_cause_description": "Other", "action": "Elekta sent Important Field Safety Notice 382-01-MON-003 to all customers on 10/16/2015. The notice informs users of the specific product and version numbers affected by both issues. The affected devices for both issues are those running Monaco 5.10.01. Customers are instructed to complete and return acknowledgement form. Solution/fix has been released in Monaco patch 5.10.02 and all affected users will be made aware of its availability by the end of October 2015.", "product_quantity": "154", "distribution_pattern": "CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom", "openfda": { "k_number": [ "K193109", "K211511", "K101076", "K002237", "K110730", "K182665", "K082221", "K993923", "K915691", "K223279", "K152488", "K203766", "K061893", "K161136", "K042739", "K100056", "K113102", "K131891", "K133247", "K222728", "K121448", "K242822", "K041997", "K140187", "K252304", "K051497", "K143269", "K200487", "K032724", "K013673", "K173635", "K080929", "K103246", "K213787", "K982821", "K041403", "K100552", "K180379", "K223724", "K123152", "K974770", "K093391", "K061097", "K071938", "K013644", "K231825", "K083414", "K160093", "K232400", "K130617", "K120551", "K062514", "K241318", "K260308", "K183037", "K090893", "K141900", "K100092", "K203681", "K211881", "K260207", "K220141", "K200569", "K041719", "K013535", "K171536", "K031349", "K002132", "K082005", "K151369", "K001295", "K983343", "K181145", "K202284", "K233236", "K241876", "K083264", "K120387", "K151560", "K222803", "K131428", "K132816", "K080888", "K112723", "K201607", "K211841", "K020027", "K100417", "K991815", "K230557", "K151666", "K192554", "K061440", "K083672", "K091179", "K151435", "K214081", "K984196", "K242748", "K010784", "K090531", "K112776", "K063482", "K081112", "K012017", "K040474", "K090808", "K990071", "K051941", "K031281", "K182888", "K102216", "K141860", "K022961", "K992303", "K222312", "K993766", "K062032", "K232479", "K000922", "K111311", "K120363", "K234068", "K032456", "K022411", "K250963", "K252002", "K200608", "K990475", "K162370", "K021268", "K103093", "K022741", "K012575", "K091492", "K191384", "K093588", "K170355", "K253078", "K992762", "K243057", "K170969", "K242992", "K994413", "K002509", "K102011", "K063230", "K050296", "K193640", "K211867", "K193381", "K992434", "K042269", "K242463", "K052325", "K253050", "K173940", "K123263", "K223233", "K151469", "K141248", "K151380", "K080601", "K133655", "K073020", "K171885", "K210645", "K982791", "K180289", "K042861", "K082606", "K211379", "K071760", "K123357", "K013112", "K211034", "K002240", "K250064", "K092928", "K260750", "K242378", "K020971", "K203469", "K090972", "K090182", "K991237", "K112446", "K083502", "K002312", "K141283", "K170750", "K982696", "K103515", "K993895", "K053584", "K102915", "K082642", "K151233", "K190178", "K142108", "K022036", "K150547", "K252109", "K252863", "K133331", "K201444", "K011246", "K250440", "K030821", "K062967", "K032345", "K022307", "K240671", "K193459", "K172163", "K252784", "K151887", "K992753", "K143514", "K013661", "K212274", "K071873", "K981678", "K040688", "K101220", "K190387", "K001700", "K253091", "K170086", "K232799", "K240398", "K081281", "K010682", "K984532", "K091146", "K112060", "K031088", "K202789", "K132971", "K002147", "K032209", "K091145", "K041971", "K101119", "K180308", "K190664", "K213438", "K992864", "K152393", "K092132", "K153368", "K192065", "K993675", "K103146", "K201350", "K220582", "K220783" ], "registration_number": [ "3003793371", "3010123525", "3006894636", "2030598", "3025765259", "8043933", "3009090417", "3022719374", "3033527281", "3003418325", "3030564015", "3014425747", "3009302839", "3044735888", "3018004899", "3009077524", "3023344262", "9617978", "3003586672", "2916710", "3014873236", "3004555507", "2434141", "2183553", "9611894", "3002808157", "3004977335", "3006579682", "3007774465", "2939248", "3012039133", "3005136058", "3003768277", "1651102", "3007037519", "3004580128", "3004363352", "3013410552", "3009529630", "3011716550", "3025309924", "3003094912", "3004608878", "3004561814", "3004526608", "1038814", "3016602874", "3007791541", "3003873069", "3010034862", "3016686005", "3019834893", "3008156050", "3019543601", "3015232217", "3042177665", "3000126629", "3015777306", "3022745617" ], "fei_number": [ "3003793371", "3010123525", "3006894636", "3025765259", "3009090417", "3022719374", "3033527281", "3003418325", "3030564015", "3008581796", "1000518731", "3014425747", "3009302839", "3044735888", "3018004899", "3009077524", "3023344262", "3003586672", "3002619595", "2916710", "3014873236", "3004555507", "2434141", "2183553", "3002808157", "3004977335", "3006579682", "3007774465", "2939248", "3012039133", "3005136058", "3007037519", "3004580128", "3002802883", "3004363352", "3013410552", "3009529630", "3011716550", "3002807880", "3025309924", "3003094912", "3004608878", "3004561814", "3004526608", "1038814", "3016602874", "3007791541", "3003873069", "3010034862", "3016686005", "3019834893", "3008156050", "3019543601", "3015232217", "3042177665", "3000126629", "3002807741", "3015777306", "3022745617" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }