{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "174511", "product_res_number": "Z-2091-2019", "event_date_initiated": "2019-07-03", "event_date_created": "2019-07-27", "recall_status": "Open, Classified", "res_event_number": "83273", "product_code": "MUJ", "k_numbers": [ "K151233" ], "product_description": "Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System", "code_info": "all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11", "firm_fei_number": "1937649", "recalling_firm": "Elekta Inc", "address_1": "13723 Riverport Dr Ste 100 13723 Riverport Dr", "address_2": "Ste 100", "city": "Maryland Heights", "state": "MO", "postal_code": "63043-4819", "additional_info_contact": "Alejandra Carrillo\n404-202-4333", "reason_for_recall": "When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.", "root_cause_description": "Under Investigation by firm", "action": "Elekta began distribution of their Important Field Safety Notice to all affected customers from 07/03/2019 by email. The notice informs users of the specific product and version numbers affected by the issue, and any work-arounds that can be used to avoid the issue.\n\nThe problem will be resolved in a future Monaco software release.", "product_quantity": "1396 units", "distribution_pattern": "worldwide", "openfda": { "k_number": [ "K000922", "K022036", "K120551", "K252863", "K211034", "K041719", "K915691", "K232400", "K220582", "K202284", "K170750", "K253050", "K011246", "K080601", "K991237", "K063482", "K141283", "K223279", "K091492", "K110730", "K151666", "K062514", "K141900", "K083414", "K113102", "K090808", "K151369", "K082642", "K223724", "K022741", "K083264", "K260308", "K091179", "K093588", "K234068", "K181145", "K260750", "K990475", "K031088", "K071760", "K111311", "K220141", "K013535", "K102915", "K201350", "K062032", "K022411", "K082221", "K080929", "K002237", "K133331", "K991815", "K002132", "K090182", "K092928", "K172163", "K001295", "K212274", "K013661", "K994413", "K222803", "K131428", "K093391", "K173635", "K202789", "K180379", "K091145", "K171536", "K242463", "K183037", "K002240", "K170969", "K223233", "K050296", "K051497", "K180289", "K152393", "K141860", "K130617", "K021268", "K230557", "K052325", "K020971", "K041997", "K203469", "K180308", "K112776", "K250963", "K220783", "K253091", "K090893", "K200487", "K981678", "K982696", "K193109", "K012575", "K231825", "K242992", "K040688", "K984196", "K182888", "K191384", "K002312", "K001700", "K100092", "K131891", "K190178", "K080888", "K214081", "K211867", "K983343", "K160093", "K232799", "K142108", "K083502", "K031281", "K992762", "K112723", "K090972", "K211881", "K002147", "K061893", "K192554", "K993766", "K082005", "K121448", "K032209", "K213438", "K993675", "K032456", "K252304", "K103093", "K082606", "K161136", "K171885", "K151380", "K150547", "K143514", "K170355", "K252784", "K042861", "K010682", "K013112", "K041971", "K241318", "K240671", "K112060", "K132816", "K162370", "K042739", "K201444", "K002509", "K100552", "K062967", "K123357", "K250440", "K992434", "K211379", "K211511", "K242378", "K013644", "K201607", "K222728", "K101076", "K210645", "K102011", "K982821", "K083672", "K992864", "K173940", "K151233", "K100417", "K151560", "K133655", "K203766", "K101220", "K103246", "K233236", "K053584", "K010784", "K222312", "K992753", "K193640", "K031349", "K974770", "K190387", "K143269", "K250064", "K081281", "K140187", "K151435", "K032724", "K133247", "K132971", "K112446", "K984532", "K182665", "K253078", "K071938", "K252002", "K151469", "K022961", "K232479", "K151887", "K203681", "K051941", "K100056", "K193381", "K200569", "K993923", "K141248", "K260207", "K030821", "K243057", "K102216", "K242748", "K190664", "K982791", "K993895", "K170086", "K213787", "K193459", "K063230", "K241876", "K032345", "K040474", "K200608", "K020027", "K990071", "K240398", "K120387", "K152488", "K013673", "K041403", "K022307", "K123263", "K123152", "K071873", "K090531", "K092132", "K103515", "K211841", "K120363", "K091146", "K042269", "K192065", "K101119", "K242822", "K103146", "K061097", "K073020", "K153368", "K992303", "K252109", "K081112", "K012017", "K061440" ], "registration_number": [ "3007037519", "3025309924", "3004977335", "3010034862", "3018004899", "3003586672", "3013410552", "2183553", "2434141", "3011716550", "8043933", "2916710", "3022719374", "3015777306", "3003094912", "3003418325", "3000126629", "3008156050", "3009090417", "3006894636", "3014873236", "3019543601", "3003768277", "3019834893", "3004363352", "3025765259", "3044735888", "3002808157", "9617978", "3014425747", "3004580128", "3015232217", "3007774465", "3003793371", "3009077524", "2030598", "3009529630", "9611894", "3005136058", "3030564015", "1651102", "3004561814", "1038814", "3010123525", "3006579682", "3004555507", "3022745617", "3033527281", "2939248", "3009302839", "3003873069", "3004526608", "3016686005", "3042177665", "3012039133", "3016602874", "3023344262", "3007791541", "3004608878" ], "fei_number": [ "3002619595", "3007037519", "3002807880", "3025309924", "3004977335", "3010034862", "3018004899", "3003586672", "3013410552", "2183553", "2434141", "3011716550", "2916710", "3002807741", "3022719374", "3015777306", "3003094912", "3003418325", "3000126629", "3008156050", "3009090417", "3006894636", "3014873236", "3019543601", "1000518731", "3019834893", "3004363352", "3025765259", "3002802883", "3044735888", "3002808157", "3014425747", "3004580128", "3015232217", "3007774465", "3003793371", "3009077524", "3005136058", "3009529630", "3030564015", "1038814", "3004561814", "3010123525", "3006579682", "3004555507", "3022745617", "3008581796", "3033527281", "2939248", "3009302839", "3003873069", "3004526608", "3016686005", "3042177665", "3012039133", "3016602874", "3023344262", "3007791541", "3004608878" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }