{ "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": "140819", "product_res_number": "Z-0170-2016", "event_date_initiated": "2015-09-28", "event_date_posted": "2015-10-30", "recall_status": "Terminated", "event_date_terminated": "2017-05-12", "res_event_number": "72374", "product_code": "MUJ", "k_numbers": [ "K093527" ], "product_description": "ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. \r\nModel number HIT\r\n\r\n\r\nProduct Usage:\r\nARIA Radiation Oncology is a radiation treatment plan and image management application.", "code_info": "Model number HIT: All units with software version 10, 11, 13.0 and 13.5 with Clinical Assessment license.", "firm_fei_number": "2916710", "recalling_firm": "Varian Medical Systems, Inc.", "address_1": "911 Hansen Way", "city": "Palo Alto", "state": "CA", "postal_code": "94304-1028", "additional_info_contact": "K. Jeffrey Semone\n650-424-6833", "reason_for_recall": "An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.", "root_cause_description": "Software design (manufacturing process)", "action": "Varian sent an Urgent Medical Device Corrections letter dated September 29, 2015 via trackable method to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Varian is developing a technical correction for this issue. Customers will be contacted by a Varian Field Service. A copy of the notification is to be kept with the most current product labeling and all appropriate personnel in the radiation oncology department should be aware of this issue. For questions contact your local Varian Medical Systems Customer Support District or\r\nRegional Manager", "product_quantity": "1971 units", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of: Canada, Switzerland, South Korea, Germany, Spain, Ireland, Spain, France, Belgium, United Arab Emirates, United Kingdom, Norway, Italy, Trinidad and Tobago, Netherlands, Philippines, Portugal, Denmark, Sweden, Belgium, Saudi Arabia, Thailand, Australia, India, Taiwan, South Africa, Israel, Australia, Kuwait, Finland, Tunisia, Algeria, Argentina, Bangladesh, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Guam, Guatemala, Hong Kong, Indonesia, Japan, Kazakhstan, Kuwait, Lebanon, Luxembourg, Madagascar, Moldova, Morocco, New Zealand, Panama, Poland, Qatar, Romania, Russia, Singapore, South Africa, Tunisia and Turkey.", "openfda": { "k_number": [ "K071873", "K180308", "K001295", "K161136", "K990475", "K031349", "K233236", "K013112", "K041997", "K112060", 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