{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "180000", "product_res_number": "Z-1464-2020", "event_date_initiated": "2020-02-20", "event_date_created": "2020-03-10", "recall_status": "Terminated", "event_date_terminated": "2024-11-05", "res_event_number": "85065", "product_code": "MUJ", "k_numbers": [ "K190387" ], "product_description": "RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system", "code_info": "UDI 07350002010129", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "additional_info_contact": "Edward Shepp\n877-7783849", "reason_for_recall": "There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.", "root_cause_description": "Under Investigation by firm", "action": "An Urgent Field Safety Notice, Medical Device Correction notification letter dated 2/19/20 was emailed to the customer.\n\nACTIONS TO BE TAKEN BY THE USER\n\" Either do not use the RayTreat tabletop propagation functionality or make sure to always perform imaging and registration correction before each treatment session.\n\" When using RayTreat in combination with the ProNova machine, do not use the acquired imaging positions in the preparation tab as the truth about where an image was actually taken.\nPlease educate all users including the planning, Quality Assurance and plan delivery staff about this workaround.\nInspect your product and identify all installed units with the above software version number(s), then 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 March 2020 (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.\nTRANSMISSION OF THIS NOTICE\nThis notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as any version of RayStation affected by this issue is in use to ensure effectiveness of the workaround.", "product_quantity": "1 system in the U.S.", "distribution_pattern": "The products were distributed to the following US states: TN", "openfda": { "k_number": [ "K000922", "K022036", "K120551", "K252863", "K211034", "K041719", "K915691", "K232400", "K220582", "K202284", "K170750", "K253050", "K011246", "K080601", "K991237", "K063482", "K141283", "K223279", "K091492", "K110730", "K151666", "K062514", "K141900", "K083414", "K113102", "K090808", "K151369", "K082642", "K223724", "K022741", "K083264", "K260308", "K091179", "K093588", "K234068", "K181145", "K260750", "K990475", "K031088", "K071760", "K111311", "K220141", "K013535", "K102915", "K201350", "K062032", "K022411", "K082221", "K080929", "K002237", "K133331", "K991815", "K002132", "K090182", "K092928", "K172163", "K001295", "K212274", "K013661", "K994413", "K222803", "K131428", "K093391", "K173635", "K202789", "K180379", "K091145", "K171536", "K242463", "K183037", "K002240", "K170969", "K223233", "K050296", "K051497", "K180289", "K152393", "K141860", "K130617", "K021268", "K230557", "K052325", "K020971", "K041997", "K203469", "K180308", "K112776", "K250963", "K220783", "K253091", "K090893", "K200487", "K981678", "K982696", "K193109", "K012575", "K231825", "K242992", "K040688", "K984196", "K182888", "K191384", "K002312", "K001700", "K100092", "K131891", "K190178", "K080888", "K214081", "K211867", "K983343", "K160093", "K232799", "K142108", "K083502", "K031281", "K992762", "K112723", "K090972", "K211881", "K002147", "K061893", "K192554", "K993766", "K082005", "K121448", "K032209", "K213438", "K993675", "K032456", "K252304", "K103093", "K082606", "K161136", "K171885", "K151380", "K150547", "K143514", "K170355", "K252784", "K042861", "K010682", "K013112", "K041971", "K241318", "K240671", "K112060", "K132816", "K162370", "K042739", "K201444", "K002509", "K100552", "K062967", "K123357", "K250440", "K992434", "K211379", "K211511", "K242378", "K013644", "K201607", "K222728", "K101076", "K210645", "K102011", "K982821", "K083672", "K992864", "K173940", "K151233", "K100417", "K151560", "K133655", "K203766", "K101220", "K103246", "K233236", "K053584", "K010784", "K222312", "K992753", "K193640", "K031349", "K974770", "K190387", "K143269", "K250064", "K081281", "K140187", "K151435", "K032724", "K133247", "K132971", "K112446", "K984532", "K182665", "K253078", "K071938", "K252002", "K151469", "K022961", "K232479", "K151887", "K203681", "K051941", "K100056", "K193381", "K200569", "K993923", "K141248", "K260207", "K030821", "K243057", "K102216", "K242748", "K190664", "K982791", "K993895", "K170086", "K213787", "K193459", "K063230", "K241876", "K032345", "K040474", "K200608", "K020027", "K990071", "K240398", "K120387", "K152488", "K013673", "K041403", "K022307", "K123263", "K123152", "K071873", "K090531", "K092132", "K103515", "K211841", "K120363", "K091146", "K042269", "K192065", "K101119", "K242822", "K103146", "K061097", "K073020", "K153368", "K992303", "K252109", "K081112", "K012017", "K061440" ], "registration_number": [ "3007037519", "3025309924", "3004977335", "3010034862", "3018004899", "3003586672", "3013410552", "2183553", "2434141", "3011716550", "8043933", "2916710", "3022719374", "3015777306", "3003094912", "3003418325", "3000126629", "3008156050", "3009090417", "3006894636", "3014873236", "3019543601", "3003768277", "3019834893", "3004363352", "3025765259", "3044735888", "3002808157", "9617978", "3014425747", "3004580128", "3015232217", "3007774465", "3003793371", "3009077524", "2030598", "3009529630", "9611894", "3005136058", "3030564015", "1651102", "3004561814", "1038814", "3010123525", "3006579682", "3004555507", "3022745617", "3033527281", "2939248", "3009302839", "3003873069", "3004526608", "3016686005", "3042177665", "3012039133", "3016602874", "3023344262", "3007791541", "3004608878" ], "fei_number": [ "3002619595", "3007037519", "3002807880", "3025309924", "3004977335", "3010034862", "3018004899", "3003586672", "3013410552", "2183553", "2434141", "3011716550", "2916710", "3002807741", "3022719374", "3015777306", "3003094912", "3003418325", "3000126629", "3008156050", "3009090417", "3006894636", "3014873236", "3019543601", "1000518731", "3019834893", "3004363352", "3025765259", "3002802883", "3044735888", "3002808157", "3014425747", "3004580128", "3015232217", "3007774465", "3003793371", "3009077524", "3005136058", "3009529630", "3030564015", "1038814", "3004561814", "3010123525", "3006579682", "3004555507", "3022745617", "3008581796", "3033527281", "2939248", "3009302839", "3003873069", "3004526608", "3016686005", "3042177665", "3012039133", "3016602874", "3023344262", "3007791541", "3004608878" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }