{ "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": "187270", "product_res_number": "Z-1598-2021", "event_date_initiated": "2021-04-07", "event_date_created": "2021-05-14", "recall_status": "Terminated", "event_date_terminated": "2023-06-02", "res_event_number": "87868", "product_code": "MUJ", "k_numbers": [ "K200569" ], "product_description": "RayStation standalone software radiation therapy treatment planning system.\nModel Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs", "code_info": "Software version number: 8.0.0.6 , 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", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options\nin Dose tracking are correct.", "root_cause_description": "Software design", "action": "On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.", "distribution_pattern": "Domestic: TN", "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" } } ] }