{ "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": "217652", "product_res_number": "Z-1106-2026", "event_date_initiated": "2025-11-28", "event_date_posted": "2026-01-16", "recall_status": "Open, Classified", "res_event_number": "98117", "product_code": "MUJ", "k_numbers": [ "K240398" ], "product_description": "Brand Name: RayStation\nProduct Name: RayStation/RayPlan\nModel/Catalog Number: 14.0.0, 15.0.0, 15.1.3\nSoftware Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3\nProduct Description: Radiation Therapy Treatment Planning System\nComponent: No", "code_info": "Lot Code: UDI: 0735000201055620230630, 0735000201072320231213, 0735000201088420250129\nGTIN: 07350002010556, 07350002010723, 07350002010884\nSerial Numbers: 14.0.0.3338, 15.0.0.430, 15.1.3.10\nSoftware Revisions: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3\nExpiration Date: 2030-02-21", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Eugeniavagen 18c 18c eugeniavagen", "city": "Stockholm", "country": "Sweden", "additional_info_contact": "Pierpaolo Sesana\n0046-85-1053000", "reason_for_recall": "Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.", "root_cause_description": "Under Investigation by firm", "action": "RaySearch Laboratories notified consignees via email on about 12/05/2025. Consignees were instructed to follow the outlined steps in the notification letter when adding geometry to an empty ROI with MO or type Bolus, Fixation or Support, educate planning staff and all users about the workaround, inspect units and identify all installed units with the affected software version numbers, and confirm receipt and understanding of the customer notification by responding to the notification email. \n\nThe issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (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. The upgrade to an unaffected software version will be scheduled in coordination with the authorized personnel, considering the specific circumstances and requirements of each individual case. The upgrade may be conducted remotely or onsite, as deemed appropriate.", "product_quantity": "119", "distribution_pattern": "Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS", "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" } } ] }