{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "158639", "product_res_number": "Z-0050-2018", "event_date_initiated": "2017-08-10", "event_date_created": "2017-10-26", "recall_status": "Terminated", "event_date_terminated": "2020-11-20", "res_event_number": "78087", "product_code": "MUJ", "k_numbers": [ "K132816" ], "product_description": "Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V.\n\nOncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.", "code_info": "Versions 4.5, 4.5.1, and 4.5.2.", "firm_fei_number": "3002807741", "recalling_firm": "Nucletron BV", "address_1": "Waardgelder 1 1 waardgelder", "address_2": "POBox 930", "city": "Veenendaal", "country": "Netherlands", "additional_info_contact": "Ms. Alejandra Carrillo\n770-670-2359", "reason_for_recall": "Incorrect source step size may occur in the software plans", "root_cause_description": "Software design", "action": "Elekta sent an Field Safety Notice notification dated August 2017, and was emailed to customers on August 10, 2017, informed users of the issue and workarounds that can be used to avoid the issue.The user is informed the issue will be resolved in a fix which will be released by the end of February 2018. Once released, the firm will proactively reach out to all affected customers to arrange a time to install the fix. An acknowledgement form was enclosed which the user was to complete to indicate they have read and understood the notice and accept implementation of any given recommendations. For further questions, please call (770) 670-2359.", "product_quantity": "89 customer sites have the affected software", "distribution_pattern": "Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam.\n\nThere was no military/government distribution.", "openfda": { "k_number": [ "K132971", "K091179", "K982696", "K915691", "K211379", "K232400", "K171885", "K201444", "K982791", "K252304", 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