{ "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": "189270", "product_res_number": "Z-2563-2021", "event_date_initiated": "2021-09-14", "event_date_created": "2021-09-24", "recall_status": "Open, Classified", "res_event_number": "88676", "product_code": "MUJ", "k_numbers": [ "K183037", "K190178" ], "product_description": "Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.", "code_info": "Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002190(10) 5.40.01, (01)00858164002190(10) 5.40.02, (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": "314-993-0003", "reason_for_recall": "Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.", "root_cause_description": "Software design", "action": "A Recall notification letter titled, \"URGENT IMPORTANT FIELD SAFETY NOTIFICATION\" was sent to consignees on 09/14/2021 via email. The letter instructs the consignee of the following: \n\n\"When using Monaco in offline mode, ensure that the active image set is selected in the workspace control when using the Auto Margin tool.\"\n\nThe consignee is to post the notice in a place that is accessible to all users until the action is closed. Furthermore, the consignee is to advise the appropriate personnel, working with this product, on the content of the letter. The firm is requesting that the consignee submit an acknowledgement form as well via the Elekta Care\" Community or complete the form and return it to Elekta immediately upon receipt, but no\nlater than within 30 days.", "product_quantity": "214 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.", "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", "K091145", 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