{ "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": "192085", "product_res_number": "Z-0732-2022", "event_date_initiated": "2021-12-30", "event_date_created": "2022-03-08", "recall_status": "Open, Classified", "res_event_number": "89631", "product_code": "MUJ", "k_numbers": [ "K211867" ], "product_description": "RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy.\nSoftware Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 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 .\nIncluding Service Paks:\nProduct name (build number) UDI-DI\nRayStation 6/RayPlan 2 (6.0.0.24) 07350002010013\nRayStation 6/RayPlan 2 Service Pack 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/RayPlan 9A (9.0.0.113) 07350002010174\nRayStation/RayPlan 9B (9.1.0.933) 07350002010266\nRayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297", "code_info": "Software: \n6.0.0.24, 6.1.0.26, 6.1.1.2, 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\n\nUDI:\n07350002010013\n07350002010082\n07350002010075\n07350002010242\n07350002010068\n07350002010112\n07350002010136\n07350002010129\n07350002010204\n07350002010235\n07350002010174\n07350002010266\n07350002010297\n07350002010013\n07350002010082\n07350002010075\n07350002010242\n07350002010068", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running", "root_cause_description": "Software design", "action": "RaySearch issued Field Safety Notice, Medical Device Correction #90375 via\n E-mail, on 30 December 2021. Letter stated reason for recall, health risk and action to take:\nDo not change the primary image set while the cine loop is running.\n\" If the primary image set has been changed while the cine loop is running, restart\nRayStation/RayPlan to restore correct behavior.\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.\n\nThis issue is resolved in RayStation/RayPlan versions 10A and higher (subject to market clearance in somemarkets). If customers wish to continue using versions of RayStation/RayPlan 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.\nPlease confirm that you have received this FSN.\nIf you want to attach a signed reply form to the email, please fill in the below. You can also fax this form to Fax: +1-631-828-2137 (US only).\n\nFor regulatory information, please contact quality@raysearchlabs.com.", "product_quantity": "75 Licenses", "distribution_pattern": "US Nationwide distribution.", "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" } } ] }