{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "200909", "product_res_number": "Z-2039-2023", "event_date_initiated": "2021-01-22", "event_date_posted": "2023-06-29", "recall_status": "Terminated", "event_date_terminated": "2023-07-03", "res_event_number": "92441", "product_code": "MUJ", "k_numbers": [ "K200569" ], "product_description": "Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.", "code_info": "UDI-DI: 07350002010129 \nUDI-DI: 07350002010204 \nUDI-DI: 07350002010235 \nUDI-DI: 07350002010174 \nUDI-DI: 07350002010266 \nUDI-DI: 07350002010297 \nUDI-DI: 07350002010303 \nUDI-DI: 07350002010365 \nUDI-DI: 07350002010310", "firm_fei_number": "3010034862", "recalling_firm": "RaySearch America Inc", "address_1": "350 5th Ave Ste 5000 350 the empire state building 5th ave", "address_2": "Ste 5000", "city": "New York", "state": "NY", "postal_code": "10118-0110", "reason_for_recall": "A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.", "root_cause_description": "Software design", "action": "Field Safety Notice 73474 was emailed January 22, 2021 to affected customers. The notice identifies affected RayStation models: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B running software versions RS 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Users are instructed not to use Create wall, Expand/Contract, or ROI algebra functions directly on ROIs created by the DL segmentation. Instead, convert the ROIs to contour or mesh representation before using the affected functions. Users are to confirm they read and understood the notice by replying to the email. Error fixed in RS 10B Service Pack 1 and corrected in the next version of RayStation.", "product_quantity": "5 systems", "distribution_pattern": "US: AZ, CA, GA & WA", "openfda": { "k_number": [ "K241876", "K041971", "K112723", "K132816", "K130617", "K180379", "K083414", "K992434", "K203681", "K082005", "K092928", "K053584", "K141283", "K101076", "K993895", "K113102", "K983343", "K093391", "K010784", "K170355", "K220783", "K243057", "K073020", "K071938", "K993923", "K131428", "K062514", "K062967", "K230557", "K013112", "K982696", "K082642", "K051497", "K061893", "K981678", "K052325", "K193381", "K031281", "K031349", "K093588", "K091179", "K242992", "K031088", "K261655", "K250064", "K151380", "K123263", "K010682", "K133331", "K022307", "K013661", "K192554", "K090531", "K232400", "K993675", "K170969", "K102011", "K151666", "K172163", "K002312", "K042861", "K012017", "K222728", "K123152", "K211511", "K040688", "K011246", "K253091", "K173940", "K123357", "K192065", "K100417", "K180308", "K041997", "K984196", "K032209", "K102915", "K151469", "K080929", "K232479", "K915691", "K091492", "K103515", "K133655", "K201444", "K202284", "K041719", "K002237", "K051941", "K090972", "K022741", "K042269", "K260207", "K151435", "K081112", "K170750", "K013673", "K152393", "K193459", "K083672", "K990475", "K250963", "K082221", "K063482", "K211881", "K020027", "K190178", "K002240", "K222803", "K151887", "K032456", "K081281", "K140187", "K182665", "K021268", "K120387", "K193109", "K101220", "K252109", "K181145", "K260750", "K112776", "K151560", "K253078", "K133247", "K992303", "K974770", "K211034", "K200569", "K211841", "K241318", "K102216", "K214081", "K100056", "K211379", "K151369", "K000922", "K982791", "K103246", "K151233", "K201350", "K083502", "K211867", "K253050", "K190387", "K252784", "K233236", "K141860", "K991237", "K213787", "K984532", "K022036", "K223233", "K223279", "K080601", "K112446", "K993766", "K092132", "K200608", "K220582", "K062032", "K183037", "K080888", "K111311", "K112060", "K120551", "K142108", "K240398", "K203469", "K190664", "K110730", "K132971", "K170086", "K240671", "K150547", "K001700", "K162370", "K143269", "K141900", "K202789", "K013644", "K201607", "K103146", "K242822", "K200487", "K101119", "K990071", "K260308", "K002132", "K040474", "K250440", "K242748", "K242378", "K153368", "K012575", "K020971", "K242463", "K001295", "K013535", "K002147", "K032724", "K090893", "K100552", "K252863", "K232799", "K231825", "K071873", "K083264", "K071760", "K022961", "K121448", "K171885", "K002509", "K141248", "K090808", "K220141", "K173635", "K143514", "K120363", "K032345", "K191384", "K252002", "K193640", "K091146", "K991815", "K212274", "K063230", "K061097", "K082606", "K131891", "K042739", "K171536", "K030821", "K222312", "K061440", "K182888", "K152488", "K100092", "K041403", "K050296", "K091145", "K090182", "K161136", "K994413", "K210645", "K223724", "K022411", "K992753", "K992762", "K160093", "K203766", "K213438", "K982821", "K180289", "K103093", "K234068", "K252304", "K992864" ], "registration_number": [ "9617978", "3009077524", "9611894", "3011716550", "3004580128", "3015777306", "3004526608", "3004555507", "3009090417", "3042177665", "3004561814", "8043933", "3016602874", "3014873236", "3016686005", "3019834893", "3023344262", "1651102", "2434141", "3007774465", "3006579682", "3004363352", "3025765259", "3009302839", "3003768277", "2183553", "3003873069", "3014425747", "3044735888", "3002808157", "3007037519", "3007791541", "3022719374", "3022745617", "3018004899", "3003793371", "3010123525", "3005136058", "3004608878", "3010034862", "3015232217", "3019543601", "3030564015", "3006894636", "2939248", "3012039133", "3013410552", "3000126629", "3003586672", "1038814", "3003094912", "3033527281", "2030598", "3004977335", "2916710", "3003418325" ], "fei_number": [ "3002807880", "3009077524", "3011716550", "3004580128", "3015777306", "3004526608", "3004555507", "3009090417", "3042177665", "3004561814", "3002802883", "3016602874", "3014873236", "3016686005", "3019834893", "3023344262", "2434141", "3007774465", "3006579682", "3004363352", "3025765259", "3009302839", "2183553", "3003873069", "3014425747", "3002807741", "3008581796", "3044735888", "3002808157", "3007037519", "3007791541", "3022719374", "3022745617", "3018004899", "3003793371", "3010123525", "3005136058", "3004608878", "3010034862", "3015232217", "3019543601", "3030564015", "3006894636", "2939248", "3012039133", "3013410552", "1000518731", "3000126629", "3003586672", "1038814", "3003094912", "3002619595", "3033527281", "3004977335", "2916710", "3003418325" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }