{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198827", "product_res_number": "Z-1233-2023", "event_date_initiated": "2023-02-28", "event_date_posted": "2023-03-08", "recall_status": "Open, Classified", "res_event_number": "91773", "product_code": "MUJ", "k_numbers": [ "K151233" ], "product_description": "Monaco RTP System. \n\nUsed to make treatment plans for patients with prescriptions for external beam radiation therapy.", "code_info": "Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; \n\nUDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03", "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": "Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.", "root_cause_description": "Software design", "action": "Elekta notified consignees of the issue on 02/28/2023 via email. Consignees were instructed to contact Elekta Care Support if assistance is needed to identify affected patients, post the recall information in a place accessible to all users until the action is complete, and complete and return the Important Field Safety Notice Acknowledgement form. Additionally, the issue is corrected in Monaco releases 5.40 and above. If you are running a 5.11.xx version, please contact Elekta Care Support to upgrade to a newer software version.", "product_quantity": "2,020 units", "distribution_pattern": "Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestinian Territory, Occupied, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Zimbabwe.", "openfda": { "k_number": [ "K102216", "K013535", "K090531", "K093588", "K151380", "K220582", "K181145", "K102011", "K171885", "K083672", "K091146", "K103246", "K121448", "K040688", "K991815", "K100056", "K063482", "K112723", "K130617", "K013112", "K242378", "K984532", "K202789", "K190178", "K011246", "K220783", "K180379", "K030821", "K162370", "K222312", "K032456", "K090808", "K082606", "K133655", "K092928", "K082005", "K093391", "K103146", "K141860", "K203681", "K992762", "K193640", "K994413", "K032345", "K180308", "K170086", "K172163", "K031349", "K151560", "K252784", "K213438", "K212274", "K160093", "K182665", "K200569", "K002240", "K974770", "K063230", "K240398", "K080601", "K133331", "K120387", "K253078", "K240671", "K042861", "K010682", "K253091", "K091145", "K000922", "K984196", "K082642", "K241876", "K013644", "K091492", "K173635", 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