{ "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": "160827", "product_res_number": "Z-0380-2018", "event_date_initiated": "2017-07-17", "event_date_created": "2018-01-17", "recall_status": "Terminated", "event_date_terminated": "2018-08-29", "res_event_number": "78900", "product_code": "MUJ", "k_numbers": [ "K171536" ], "product_description": "RayStation \n\nProduct Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.", "code_info": "6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavaegen 9 9 sveavaegen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.", "root_cause_description": "Device Design", "action": "Ray Search sent a Field Safety Notice letter dated July 14, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a response form with instructions for workarounds until the software is corrected.", "product_quantity": "117 units", "distribution_pattern": "US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.", "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" } } ] }