{ "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": 2 } }, "results": [ { "cfres_id": "176158", "product_res_number": "Z-2560-2019", "event_date_initiated": "2019-09-04", "event_date_created": "2019-09-25", "recall_status": "Open, Classified", "res_event_number": "83692", "product_code": "MUJ", "k_numbers": [ "K183037" ], "product_description": "Monaco RTP System, 5.40 Unity, radiation treatment planning system\n\nProduct Usage:\nThe Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review", "code_info": "UDI (01)00858164002190(10) 5.40.00", "firm_fei_number": "1937649", "recalling_firm": "Elekta Inc", "address_1": "13723 Riverport Dr Ste 100 13723 Riverport Dr", "address_2": "Ste 100", "city": "Maryland Heights", "state": "MO", "postal_code": "63043-4819", "reason_for_recall": "It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.", "root_cause_description": "Software design", "action": "The firm notified their consignees of the issue by email on 09/04/2019. The letter explained the problem and the workaround and requested the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and that all appropriate personnel working with the product be advised of the content of the letter.", "product_quantity": "30 units", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK", "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", 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