{ "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": "194595", "product_res_number": "Z-1403-2022", "event_date_initiated": "2022-06-01", "event_date_created": "2022-07-19", "recall_status": "Terminated", "event_date_terminated": "2023-10-04", "res_event_number": "90498", "product_code": "MUJ", "k_numbers": [ "K200569" ], "product_description": "RayStation 9B SP1. For radiation treatment planning.", "code_info": "UDI-DI: 0735000201029720200310\nBuild number 9.2.0.483", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.", "root_cause_description": "Software change control", "action": "The firm contacted all customers via email on June 1, 2022. Customers were provided with a list of workflows where safety related information may not be propagated.\n\nCustomers were instructed to be aware that treatment course information in RayCare may not always be up to date. Customers should verify critical information in RayStation or RayTreat before treatment course information in RayCare is used for critical decisions.\n\nCustomers were asked to identify all installed units with the affected software version numbers.\n\nThe issue will be resolved in mandatory software updates for RayStation, scheduled for market release in June 2022.", "product_quantity": "1", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.", "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", 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"device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }