{ "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": "181065", "product_res_number": "Z-1825-2020", "event_date_initiated": "2020-04-16", "event_date_created": "2020-04-29", "recall_status": "Open, Classified", "res_event_number": "85425", "product_code": "MUJ", "k_numbers": [ "K183037" ], "product_description": "Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The", "code_info": "Software Build: 5.40.00 (UDI: (01)00858164002190(10) 5.40.00), 5.40.01 (UDI: 01)00858164002190(10) 5.40.01)", "firm_fei_number": "1937649", "recalling_firm": "Elekta Inc", "address_1": "1450 Beale St Ste 205 1450 Beale St", "address_2": "Ste 205", "city": "Saint Charles", "state": "MO", "postal_code": "63303", "additional_info_contact": "Mark Roman\n314-993-0003", "reason_for_recall": "The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.", "root_cause_description": "Software design", "action": "In April of 2020, Elekta Inc. prepared an Urgent/Important Field Safety Notice identifying this issue, the actions that should be taken by the user/customer in order to prevent risks for patients and/or users, and the actions planned by Elekta to correct the problem. PRODUCT: The Monaco RTP System with versions 5.40 or 5.40.01 installed in or after June of 2018. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Customers/users are instructed to follow their standard clinical practice of reviewing plans, including the review of contours and volumes. DVHs that show unexpected overdose or under-dose should be investigated by the customer/user. The customer/user should post the issued notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and to advise the appropriate personnel who are working with this product on the content of this letter. Customers/users are also required to either acknowledge receipt of this notification via the Elekta Care Community or complete the provided acknowledgement form and return it to Elekta immediately upon receipt, but no later than within 30 days of receiving the notification letter.", "product_quantity": "96 devices", "distribution_pattern": "Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.", "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", 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