{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150009", "product_res_number": "Z-0076-2017", "event_date_initiated": "2016-09-29", "event_date_created": "2016-10-13", "recall_status": "Terminated", "event_date_terminated": "2021-07-16", "res_event_number": "75303", "product_code": "MUJ", "k_numbers": [ "K151233" ], "product_description": "Monaco RTP System\nThe Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups", "code_info": "Software Builds 5.10 and 5.20", "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": "Joseph Carter\n770-670-2422", "reason_for_recall": "When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.", "root_cause_description": "Device Design", "action": "Elekta sent an Important Field Safety Notice 382-01-MON-005 was sent to all affected customers on 9/29/2016. The notice informs users of the specific product and version numbers affected by the issue,and any work arounds that can be used to avoid the issue. The notice included an acknowledgment form which is to be returned.\nFor questions regarding this recall call 314-993-0003 or 800-878-4287.", "product_quantity": "365", "distribution_pattern": "Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI. Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.", "openfda": { "k_number": [ "K071873", "K180308", "K001295", "K161136", "K990475", "K031349", "K233236", "K013112", "K041997", "K112060", "K242992", "K993675", "K160093", "K181145", "K121448", "K130617", "K173940", "K172163", "K250963", "K090531", "K012017", "K203766", "K013535", "K062032", "K082221", "K152393", "K220582", "K080601", "K123152", "K002237", "K091179", "K201350", "K170355", "K090182", "K200487", "K123357", "K241318", "K252784", "K011246", "K992753", "K041719", "K021268", "K243057", "K093391", "K082606", "K132816", "K010784", 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