{ "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": "183197", "product_res_number": "Z-2899-2020", "event_date_initiated": "2020-07-29", "event_date_created": "2020-08-27", "recall_status": "Open, Classified", "res_event_number": "86249", "product_code": "MUJ", "k_numbers": [ "K200487" ], "product_description": "RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.", "code_info": "Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621\"", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.", "root_cause_description": "Under Investigation by firm", "action": "Only 1 effected consignee who was emailed a field safety notice on 08/05/2020. This letter instructs the user to:\nBe aware that registration of a treatment image with a corresponding study with multiple series in the same frame of reference might block the offline image review. Verify the correctness of the data in RayCare PACS before using the data for any decision making.\n-Please educate 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.", "distribution_pattern": "US Nationwide distribution including in the state of Tennessee.", "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", 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Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }