{ "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": "188227", "product_res_number": "Z-2138-2021", "event_date_initiated": "2021-06-08", "event_date_created": "2021-07-23", "recall_status": "Terminated", "event_date_terminated": "2024-03-20", "res_event_number": "88258", "product_code": "MUJ", "k_numbers": [ "K200487", "K200569" ], "product_description": "RayStation (Radiation Treatment Planning System) :\nRayStation 9A, 9B, 9B SP1, 10A, 10A\nSP1, 10B and 11A, in combination with RayCare\nModel Numbers/ UDI:\nRayStation 9.0 (9.0.0.113) 07350002010174;\nRayStation 9.1 (9.1.0.933) 07350002010266;\nRayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297;\nRayStation 10.0 (10.0.0.1154) 07350002010303;\nRayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365;\nRayStation 10.1 (10.1.0.613) 07350002010310;\nRayStation 11.0 (11.0.0.951) 07350002010389;", "code_info": "Product name (build number) UDI-DI\nRayStation 9.0 (9.0.0.113) 07350002010174\nRayStation 9.1 (9.1.0.933) 07350002010266\nRayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297\nRayStation 10.0 (10.0.0.1154) 07350002010303\nRayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365\nRayStation 10.1 (10.1.0.613) 07350002010310\nRayStation 11.0 (11.0.0.951) 07350002010389", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.", "root_cause_description": "Under Investigation by firm", "action": "RaySearch issued Urgent Field Safety Notice, Medical Device Correction #80230 via email on 06/08/21. Letter states reason for recall, health risk and action to take:\nTO BE TAKEN BY THE USER\n\" Do not create setup beams with the localization point as isocenter (option 2).\n\" Always perform secondary verification of new treatment positions. RayTreat will notify the user when the treatment positions have been updated.\n\" Always perform imaging before treating the patient.\n\" 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.\nSOLUTION\nThis issue will be resolved in the next version of RayStation, scheduled for market release in June 2021 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.\nFor regulatory information, please contact quality@raysearchlabs.com.", "product_quantity": "5 units", "distribution_pattern": "US distribution to TN; and Belgium", "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" } } ] }