{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184282", "product_res_number": "Z-0478-2021", "event_date_initiated": "2020-10-08", "event_date_created": "2020-11-20", "recall_status": "Terminated", "event_date_terminated": "2023-03-30", "res_event_number": "86668", "product_code": "MUJ", "k_numbers": [ "K200569" ], "product_description": "RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.", "code_info": "Software version numbers:   4.0.0.14 , 4.0.3.4 , 4.5.1.14 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 ,; 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "If a region of interest (ROI)\nor point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure\nSet, the reference may become linked to the wrong ROI or POI.", "root_cause_description": "Software design", "action": "On October 8, 2020, the firm emailed \"Field Safety Notice, Medical Device Correction #66704\" to affected customers.\n\nCustomers were made aware of the product issue and asked to take the following actions:\n\n\" Do not exclude the prescription ROI or POI when exporting from RayStation with the Exclude from\nexport option.\n\" If an RT Structure Set where it is not certain that all referenced bolus and prescription ROIs or\nPOIs are present is imported to RayStation, make sure to check that any intended references to\nbolus and prescription are correct after import.\n\" Please educate planning staff and all users about this workaround.\n\" Inspect your product and identify all installed units with the above software version number(s).\n\" Confirm you have read and understood this notice by replying to the notification email.\n\nThis issue will be resolved in the next version of RayStation, scheduled for market release in November\n2020 (subject to market clearance in some markets). If customers wish to continue using versions of\nRayStation affected by this notice, all users must maintain awareness of this notice. Alternatively,\ncustomers can choose to upgrade to the new version once it becomes available for clinical use.\n\nFor regulatory information, please contact quality@raysearchlabs.com", "product_quantity": "2768", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K180308", "K170969", "K203469", "K231825", "K002132", "K994413", "K203766", "K201350", "K192065", "K202284", "K200569", "K032724", "K993895", "K002237", "K103515", "K010784", "K100417", "K013112", "K090808", "K190178", "K100092", "K990475", "K992864", "K151560", "K252863", "K133331", "K013661", "K103093", "K252784", "K092132", "K992303", "K151233", "K193109", "K022307", "K152393", "K915691", "K151887", "K092928", "K212274", "K090893", "K062967", "K002240", "K172163", "K201444", "K080929", "K080601", "K082642", "K250440", "K100552", "K190387", "K992434", "K250963", "K992753", "K123263", "K991237", "K120387", "K040688", "K101119", "K211881", "K042861", "K173635", "K242992", "K021268", "K190664", "K214081", "K090531", "K252109", "K091145", "K170750", "K220141", "K993675", "K203681", "K990071", "K071760", "K211379", "K222803", "K123152", "K082005", "K032345", "K113102", "K013673", "K222728", "K260207", "K240671", "K233236", "K002312", "K062032", "K102011", "K142108", "K192554", "K211841", "K161136", "K211034", "K200608", "K081281", "K200487", "K062514", "K121448", "K242822", "K090972", "K002147", "K080888", "K071938", "K201607", "K151380", "K030821", "K013535", "K100056", "K041403", "K162370", "K112723", "K993766", "K082606", "K063230", "K132816", "K150547", "K093391", "K031088", "K133247", "K050296", "K040474", "K151469", "K051497", "K071873", "K152488", "K091179", "K180289", "K041997", "K151369", "K180379", "K243057", "K083502", "K053584", "K181145", "K020971", "K133655", "K111311", "K210645", "K234068", "K011246", "K982821", "K143514", "K984196", "K091492", "K010682", "K102216", "K083264", "K984532", "K000922", "K132971", "K982696", "K141283", "K171885", "K140187", "K042739", "K131891", "K022961", "K983343", "K083414", "K223233", "K041971", "K170355", "K001295", "K052325", "K022741", "K012017", "K183037", "K991815", "K232799", "K253078", "K032456", "K252304", "K170086", "K974770", "K981678", "K031349", "K171536", "K141248", "K222312", "K253050", "K182665", "K061440", "K031281", "K151666", "K191384", "K063482", "K112776", "K193640", "K061097", "K223724", "K223279", "K211867", "K260750", "K112060", "K241318", "K101220", "K090182", "K103146", "K130617", "K993923", "K160093", "K051941", "K013644", "K252002", "K992762", "K112446", "K110730", "K012575", "K202789", "K173940", "K082221", "K022411", "K041719", "K032209", "K242748", "K141860", "K022036", "K061893", "K193459", "K241876", "K001700", "K091146", "K232479", "K242463", "K073020", "K240398", "K260308", "K081112", "K042269", "K230557", "K211511", "K143269", "K220783", "K232400", "K020027", "K093588", "K213438", "K250064", "K102915", "K101076", "K002509", "K151435", "K213787", "K242378", "K220582", "K141900", "K982791", "K120551", "K103246", "K120363", "K153368", "K123357", "K193381", "K253091", "K182888", "K131428", "K083672" ], "registration_number": [ "3002808157", "2939248", "3023344262", "3015232217", "3009302839", "3022719374", "3011716550", "3015777306", "3019543601", "3009090417", "8043933", "3022745617", "3003768277", "3025309924", "3044735888", "3000126629", "3018004899", "2030598", "3042177665", "3003094912", "3012039133", "3033527281", "2916710", "3003873069", "3004580128", "3025765259", "3004363352", "3007774465", "9611894", "3003586672", "3014425747", "2183553", "3009077524", "3009529630", "3013410552", "3006579682", "3006894636", "3030564015", "3003418325", "3004526608", "3016686005", "3010123525", "3005136058", "3019834893", "3003793371", "3007037519", "9617978", "3004977335", "3014873236", "3004608878", "3004555507", "3010034862", "1038814", "3007791541", "3016602874", "3008156050", "1651102", "2434141", "3004561814" ], "fei_number": [ "3002808157", "2939248", "3023344262", "3002807741", "3015232217", "3009302839", "1000518731", "3022719374", "3011716550", "3015777306", "3019543601", "3009090417", "3022745617", "3044735888", "3025309924", "3008581796", "3000126629", "3002807880", "3018004899", "3042177665", "3003094912", "3012039133", "3002619595", "3033527281", "2916710", "3003873069", "3004580128", "3025765259", "3004363352", "3007774465", "3003586672", "3014425747", "2183553", "3009077524", "3009529630", "3013410552", "3006579682", "3006894636", "3030564015", "3003418325", "3004526608", "3016686005", "3010123525", "3005136058", "3019834893", "3003793371", "3007037519", "3002802883", "3004977335", "3014873236", "3004608878", "3004555507", "3010034862", "1038814", "3007791541", "3016602874", "3008156050", "2434141", "3004561814" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }