{ "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": "215505", "product_res_number": "Z-2491-2025", "event_date_initiated": "2025-08-08", "event_date_posted": "2025-09-02", "recall_status": "Open, Classified", "res_event_number": "97400", "product_code": "MUJ", "k_numbers": [ "K211867" ], "product_description": "RayStation with the following product descriptions: \n\n1. RayStation 11A, Software Version: 11.0.0.951.\n\n2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29.\n\n3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116.\n\n4. RayStation 11A Service Pack 3, Software Version: 11.0.4.15.\n\n\nProduct Description: Radiation Therapy Treatment Planning System.", "code_info": "1. Software Version: 11.0.0.951, UDI: 0735000201038920210518.\n\n2. Software Version: 11.0.1.29, UDI: 0735000201043320210610.\n\n3. Software Version: 11.0.3.116, UDI: 0735000201044020210916.\n\n4. Software Version: 11.0.4.15, UDI: 0735000201063120220616.\n\n\nExpiration Date: 2027-06-22", "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": "DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.", "root_cause_description": "Under Investigation by firm", "action": "RaySearch notified consignees on about 08/08/2025 via email. Consignees were informed that as temporary solution, affected objects can be re-exported via RayGateway to generate new UIDs. They were instructed to inform planning staff and all users about this workaround, inspect your product and identify all installed units with the above software version number(s), and complete and return the response form. The issue will be resolved in the next version of RayStation, scheduled for market release in December\n2025 (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.", "product_quantity": "3", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.", "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", 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"device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }