{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194605", "product_res_number": "Z-1299-2022", "event_date_initiated": "2022-06-10", "event_date_created": "2022-06-28", "recall_status": "Terminated", "event_date_terminated": "2024-06-11", "res_event_number": "90505", "product_code": "MUJ", "k_numbers": [ "K220141" ], "product_description": "RayStation 11B", "code_info": "UDI-DI 0735000201042620211208\nSoftware version numbers\n12.0.0.932, 12.1.0.1221, 12.0.3.68", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation \n11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display\nmight be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync \nwith the selected beam.", "root_cause_description": "Under Investigation by firm", "action": "The firm notified customers of the recall via email on June 10, 2022. The notice was titled \"Field Safety Notice, Medical Device Correction #99834.\"\n\nCustomers were given precautions and instructed on a workaround.\n\nThe issue will be resolved in the next version of RayStation, scheduled for market release in June 2022, though this may be subject to market clearance.", "product_quantity": "26", "distribution_pattern": "US Nationwide distribution in the states of NJ and TX.", "openfda": { "k_number": [ "K100417", "K013535", "K062514", "K253091", "K090182", "K063482", "K160093", "K013673", "K010682", "K090972", "K984196", "K170086", "K022741", "K002240", "K051497", "K101076", "K211034", "K151380", "K113102", "K223233", "K170355", "K091146", "K150547", "K080888", "K211841", "K062967", "K234068", "K082606", "K994413", "K171885", "K211867", "K260207", "K083414", "K192554", "K260308", "K081281", "K013644", "K211511", "K222803", "K190664", "K123263", "K002509", "K002147", "K061440", "K130617", "K143514", "K190178", "K012017", "K231825", "K140187", "K201607", "K062032", "K032724", "K250963", "K103093", "K230557", "K990475", "K213787", "K102011", "K100092", "K080929", "K193109", "K031349", "K151469", "K141283", "K993895", "K242992", "K032209", "K233236", "K182888", "K252109", "K241876", "K240671", "K991815", "K041997", "K132816", "K173635", "K991237", "K040474", "K022036", "K032345", "K083672", "K253078", "K152393", "K232400", "K090893", "K051941", "K203766", "K983343", "K042861", "K192065", "K193640", "K101220", "K083264", "K141900", "K203681", "K992762", "K103146", "K240398", "K092132", "K151369", "K180379", "K061893", "K171536", "K050296", "K022307", "K982696", "K993675", "K141860", "K121448", "K002132", "K200608", "K990071", "K061097", "K151887", "K103515", "K222312", "K031088", "K001295", "K213438", "K142108", "K232479", "K242378", "K210645", "K190387", "K161136", "K220141", "K153368", "K022961", "K080601", "K101119", "K201444", "K241318", "K203469", "K082005", "K212274", "K992434", "K183037", "K181145", "K091179", "K111311", "K110730", "K103246", "K151666", "K052325", "K133247", "K232799", "K211881", "K151560", "K012575", "K123152", "K974770", "K214081", "K021268", "K071938", "K981678", "K020971", "K141248", "K002237", "K220783", "K200487", "K223279", "K100056", "K222728", "K042269", "K133655", "K100552", "K250064", "K102915", "K250440", "K182665", "K082642", "K992864", "K090531", "K984532", "K092928", "K191384", "K071873", "K132971", "K202284", "K112060", "K090808", "K200569", "K220582", "K001700", "K042739", "K091145", "K112446", "K041719", "K010784", "K151435", "K261655", "K170969", "K252002", "K253050", "K162370", "K992753", "K223724", "K102216", "K993766", "K180289", "K081112", "K120387", "K112723", "K011246", "K031281", "K013661", "K013112", "K193459", "K993923", "K173940", "K123357", "K201350", "K202789", "K030821", "K243057", "K982791", "K000922", "K040688", "K131428", "K242748", "K082221", "K071760", "K252784", "K151233", "K093391", "K143269", "K170750", "K020027", "K120363", "K982821", "K252863", "K093588", "K242463", "K915691", "K053584", "K152488", "K120551", "K073020", "K252304", "K041403", "K002312", "K211379", "K112776", "K180308", "K083502", "K133331", "K172163", "K260750", "K032456", "K041971", "K193381", "K022411", "K131891", "K242822", "K063230", "K091492", "K992303" ], "registration_number": [ "3010034862", "3000126629", "3005136058", "3044735888", "9617978", "3006579682", "3023344262", "1651102", "3012039133", "2183553", "3003418325", "8043933", "9611894", "3015777306", "3004555507", "3009077524", "3003873069", "3004526608", "3003094912", "3007791541", "3022719374", "3002808157", "3022745617", "3009302839", "3004977335", "3013410552", "3003768277", "3016602874", "3019543601", "2939248", "3016686005", "3004580128", "3019834893", "2030598", "3006894636", "2916710", "3009090417", "3007774465", "3014873236", "3025765259", "3004363352", "3011716550", "3033527281", "1038814", "3014425747", "3018004899", "3003586672", "3010123525", "3003793371", "3007037519", "3004608878", "3042177665", "3004561814", "3015232217", "2434141", "3030564015" ], "fei_number": [ "3010034862", "3000126629", "3005136058", "3002807880", "3002802883", "3044735888", "3002619595", "3006579682", "3023344262", "3012039133", "2183553", "3003418325", "3008581796", "3015777306", "3004555507", "3009077524", "3003873069", "3004526608", "3003094912", "3007791541", "3022719374", "3002808157", "3022745617", "3009302839", "3004977335", "3013410552", "3016602874", "3019543601", "2939248", "3016686005", "3004580128", "3002807741", "3019834893", "3006894636", "2916710", "3009090417", "1000518731", "3007774465", "3014873236", "3025765259", "3004363352", "3011716550", "3033527281", "1038814", "3014425747", "3018004899", "3003586672", "3010123525", "3003793371", "3007037519", "3004608878", "3042177665", "3004561814", "3015232217", "2434141", "3030564015" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }