{ "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": "148383", "product_res_number": "Z-0079-2017", "event_date_initiated": "2016-05-30", "event_date_created": "2016-10-13", "recall_status": "Terminated", "event_date_terminated": "2017-09-22", "res_event_number": "74750", "product_code": "MUJ", "k_numbers": [ "K160093" ], "product_description": "Radiation Therapy Treatment Planning System, Model 5.0", "code_info": "5.0.0.37, 5.0.1.11 and 5.0.2.35", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavaegen 9 9 sveavaegen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.", "root_cause_description": "Software design", "action": "On May 19th, 2016, RaySearch Laboratories distributed Field Safety Notice, Medical Device Correction notices and reply forms to their customers via email. Actions to be taken by the customer include: 1) Inspect all report templates that are intended to be used for plans with multiple beam sets. 2) Make sure that POI Dose statistics (Plan) is included immediately before ROI Dose statistics [Plan dose] in the Report content area. 3) Please educate planning staff and all users about this workaround. 4) Inspect your product and identify all installed units with the above software version number. Finally, complete and return the reply form via email to: freddie.cardel@raysearchlabs.com or by fax to: 888-501-7195 to confirm that you have read and understand the information. Customers with questions can contact David Hedfors via email: david.hedfors@raysearchlabs.com", "product_quantity": "491 units (187 domestically & 304 internationally)", "distribution_pattern": "AZ, CA, FL, MT, NC NY, TX, OH & WA", "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" } } ] }