{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192432", "product_res_number": "Z-0848-2022", "event_date_initiated": "2021-09-09", "event_date_created": "2022-03-31", "recall_status": "Terminated", "event_date_terminated": "2024-04-16", "res_event_number": "89788", "product_code": "MUJ", "k_numbers": [ "K210645" ], "product_description": "TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A.\nBuild Numbers:\n6.1.1.2, 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, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.", "code_info": "Name (build number) UDI-DI:\nRayStation 6/RayPlan 2 Service Pack 1 (6.1.0.26) 07350002010037\nRayStation 6/RayPlan 2 Service Pack 1 v.6.1.1 (6.1.1.2) 07350002010082\nRayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075\nRayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242\nRayStation/RayPlan 7 (7.0.0.19) 07350002010068\nRayStation/RayPlan 8A (8.0.0.61) 07350002010112\nRayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136\nRayStation/RayPlan 8B (8.1.0.47) 07350002010129\nRayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204\nRayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235\nRayStation 9A (9.0.0.113) 07350002010174\nRayStation 9B (9.1.0.933) 07350002010266\nRayStation Service Pack 1 (9.2.0.483) 07350002010297\nRayStation 10A (10.0.0.1154) 07350002010303\nRayStation 10A Service Pack 1 (10.0.1.52) 07350002010365\nRayStation 10B (10.1.0.613) 07350002010310\nRayStation 11A (11.0.0.951) 07350002010389\nRayStation 11A Service Pack 1 (11.0.1.29) 07350002010433", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during\ntreatment planning", "root_cause_description": "Under Investigation by firm", "action": "RaySearch issued Field Safety Notice, Medical Device Correction #83773 notice via email on Sept. 9, 2021. Letter states reason for recall, health risk and action to take:\nACTIONS TO BE TAKEN BY THE USER\n\" Avoid changing the dose grid after starting an optimization of TomoHelical and TomoDirect plans with dynamic jaw mode.\n\" Always reset the optimization after editing the dose grid for TomoHelical and TomoDirect plans with dynamic jaw mode.\n\" Always reset the optimization after modifying the target ROI.\n\" It is recommended to use the BEV to inspect the jaw positions superior and inferior to the target dynamic jaw mode.\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 October 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.\n\nFor regulatory information, please contact quality@raysearchlabs.com.", "product_quantity": "51 (US) Licenses", "distribution_pattern": "US Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS, NC, OK, OR, SC, \nTN, WA, WI.", "openfda": { "k_number": [ "K132971", "K091179", "K982696", "K915691", "K211379", "K232400", "K171885", "K201444", "K982791", "K252304", "K012017", "K242992", "K211034", "K142108", "K041403", "K011246", "K041719", "K100056", "K160093", "K983343", "K180379", "K123263", "K051497", "K022036", "K991815", "K211841", "K260308", "K042269", "K100417", "K220783", "K082221", "K051941", "K100552", "K002312", "K201607", "K223279", "K151666", "K032724", "K210645", "K984532", "K150547", "K993675", "K133331", "K112723", "K081281", "K013112", "K211511", "K253078", "K994413", "K202789", "K013673", "K992762", "K090972", "K240671", "K182665", "K083264", "K133247", "K041971", "K192065", "K010682", "K022411", "K090531", "K151560", "K170086", "K090182", "K151887", "K002147", "K172163", "K252109", "K203469", "K032345", "K190664", "K063482", "K002509", "K080888", "K133655", "K111311", "K151380", "K213438", "K162370", "K220582", "K101076", "K991237", "K061097", "K200569", "K213787", "K250963", "K091146", "K193109", "K974770", "K042739", "K202284", "K092132", "K112060", "K081112", "K141283", "K091492", "K113102", "K022307", "K102216", "K042861", "K063230", "K020027", "K170750", "K061440", "K120363", "K200608", "K220141", "K241318", "K012575", "K123152", "K242748", "K232799", "K252002", "K022741", "K031349", "K062967", "K121448", "K152393", "K141860", "K173940", "K992864", "K013644", "K222312", "K100092", "K203766", "K242378", "K193640", "K252863", "K243057", "K222803", "K990475", "K032456", "K040474", "K253050", "K993766", "K140187", "K161136", "K131891", "K141900", "K200487", "K050296", "K103093", "K071938", "K082005", "K083414", "K203681", "K001295", "K993923", "K182888", "K021268", "K123357", "K993895", "K151435", "K151369", "K233236", "K093588", "K092928", "K101220", "K080601", "K141248", "K214081", "K240398", "K013661", "K061893", "K211881", "K211867", "K990071", "K071760", "K002132", "K242822", "K143514", "K120387", "K250064", "K082642", "K223724", "K231825", "K222728", "K992434", "K170969", "K001700", "K062514", "K153368", "K982821", "K080929", "K071873", "K151469", "K031088", "K260207", "K053584", "K010784", "K191384", "K992753", "K093391", "K170355", "K030821", "K041997", "K130617", "K151233", "K192554", "K252784", "K132816", "K131428", "K013535", "K171536", "K031281", "K083672", "K110730", "K002237", "K103246", "K040688", "K193381", "K103146", "K082606", "K190178", "K052325", "K223233", "K260750", "K984196", "K212274", "K020971", "K022961", "K032209", "K181145", "K102915", "K981678", "K183037", "K230557", "K992303", "K112446", "K120551", "K201350", "K241876", "K102011", "K143269", "K090808", "K190387", "K002240", "K112776", "K234068", "K250440", "K180308", "K232479", "K083502", "K090893", "K000922", "K242463", "K091145", "K173635", "K101119", "K103515", "K073020", "K180289", "K062032", "K253091", "K193459", "K152488" ], "registration_number": [ "1038814", "2030598", "8043933", "3019834893", "3012039133", "3014425747", "3016686005", "3003873069", "3009529630", "2183553", "3004555507", "3011716550", "3025309924", "3003418325", "3000126629", "3007791541", "9617978", "3044735888", "1651102", "3002808157", "3008156050", "3003586672", "3003793371", "3009090417", "3004363352", "3005136058", "3014873236", "3025765259", "3006579682", "3019543601", "3006894636", "3015777306", "3004561814", "3010034862", "3013410552", "3009302839", "9611894", "3010123525", "3003094912", "3007037519", "3004580128", "3022719374", "2916710", "3022745617", "3018004899", "3004608878", "2939248", "3004977335", "3030564015", "3007774465", "3009077524", "3016602874", "3042177665", "3015232217", "3023344262", "3033527281", "2434141", "3003768277", "3004526608" ], "fei_number": [ "1038814", "3019834893", "3012039133", "3014425747", "3016686005", "3003873069", "3002619595", "3009529630", "2183553", "3004555507", "3011716550", "3025309924", "3003418325", "3000126629", "3007791541", "3044735888", "3002807741", "3002808157", "3008156050", "3003586672", "3003793371", "3009090417", "3004363352", "3005136058", "3014873236", "3002807880", "3025765259", "3006579682", "3019543601", "3006894636", "3015777306", "3002802883", "3004561814", "3010034862", "3013410552", "3009302839", "3003094912", "3010123525", "3007037519", "3004580128", "3022719374", "2916710", "3022745617", "3018004899", "3004608878", "2939248", "3004977335", "3030564015", "3007774465", "1000518731", "3009077524", "3016602874", "3008581796", "3042177665", "3015232217", "3023344262", "3033527281", "2434141", "3004526608" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }