{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188703", "product_res_number": "Z-2406-2021", "event_date_initiated": "2021-07-26", "event_date_created": "2021-09-02", "recall_status": "Open, Classified", "res_event_number": "88451", "product_code": "MUJ", "k_numbers": [ "K183037", "K190178" ], "product_description": "Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10", "code_info": "Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10\n\nUDI:\n(01)00858164002190(10) 5.40.00\n(01)00858164002190(10) 5.40.01\n(01)00858164002190(10) 5.40.02\n(01)00858164002268(10) 5.51.10", "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": "If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.", "root_cause_description": "Under Investigation by firm", "action": "Elekta will send an Important Field Safety Notice 382-01-MON-019 to all affected customers beginning August 10, 2021. The notice informs users of the specific product and version numbers affected by the issue, and any workaround that can be used to avoid the issue. \n\nA copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are asked to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible, but no later than 30 days after receipt.\n\nThis issue is expected to be addressed in a future Monaco release, tentatively scheduled for the end of June 2022.", "distribution_pattern": "Distribution in US - IA, NJ, NY, TN, PA, TX, and WI\n\nOUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom", "openfda": { "k_number": [ "K151233", "K193640", "K182665", "K202284", "K260207", "K083264", "K242378", "K082005", "K992434", "K990475", "K974770", "K190178", "K990071", "K151435", "K170969", "K192554", "K234068", "K062967", "K202789", "K233236", "K211841", "K090972", "K181145", "K211379", "K071938", "K252784", "K223279", "K143269", "K022411", "K240671", "K022036", "K151380", "K040474", "K020027", 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