{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "140260", "product_res_number": "Z-0112-2016", "event_date_initiated": "2015-09-15", "event_date_posted": "2015-10-07", "recall_status": "Terminated", "event_date_terminated": "2017-04-04", "res_event_number": "72221", "product_code": "MUJ", "k_numbers": [ "K151233" ], "product_description": "Monaco Radiation Treatment Planning System.\n\nUsed to make treatment plans for patients with prescriptions for external beam radiation therapy.", "code_info": "Software Version 5.10.00", "firm_fei_number": "1037831", "recalling_firm": "Elekta, Inc.", "address_1": "400 Perimeter Center Ter NE Ste 50 400 Perimeter Center Ter NE", "address_2": "Ste 50", "city": "Atlanta", "state": "GA", "postal_code": "30346-1227", "additional_info_contact": "Linda Wetsel\n404-993-5886", "reason_for_recall": "Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.", "root_cause_description": "Device Design", "action": "The firm issued an URGENT IMPORTANT FIELD SAFETY NOTICE on 09/15/2015. The letter identified the affected device, as well as the reason for the recall, and clinical impact. Customers were informed that both issues would be resolved in Monaco Patch Release 5.10.01. The attached acknowledgement form should be completed, signed, and returned to a local Elekta Office or representative within 30 days. Questions regarding the notice should be directed to a local Elekta office.", "product_quantity": "154 units", "distribution_pattern": "Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.", "openfda": { "k_number": [ "K180308", "K170969", "K203469", "K231825", "K002132", "K994413", "K203766", "K201350", "K192065", "K202284", "K200569", "K032724", "K993895", "K002237", "K103515", "K010784", "K100417", "K013112", "K090808", "K190178", "K100092", "K990475", "K992864", "K151560", "K252863", "K133331", "K013661", "K103093", "K252784", "K092132", "K992303", "K151233", "K193109", "K022307", "K152393", "K915691", "K151887", "K092928", "K212274", "K090893", "K062967", "K002240", "K172163", "K201444", "K080929", "K080601", "K082642", "K250440", "K100552", "K190387", "K992434", "K250963", "K992753", "K123263", "K991237", "K120387", "K040688", "K101119", 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