{ "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": "92423", "product_res_number": "Z-0455-2011", "event_date_initiated": "2010-05-13", "event_date_posted": "2010-11-24", "recall_status": "Terminated", "event_date_terminated": "2012-02-24", "res_event_number": "56012", "product_code": "MUJ", "k_numbers": [ "K071873", "K932501" ], "product_description": "Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x;\n\nModel Numbers: H48/H83.", "code_info": 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AMENDED INFO ***: H486595, H483731, H482698, H485342, H486871, H486678, H481340, H487526, H489843, H48B780, H483224, H487910, H484784, H484935, H485543, H480930, H481426, H481427, H486709, H486679, H486787, H483818, H488101, H488634, H488635, H488794, H486673, H487706, H487707, H485913, H482645, H831252M, H831252R1, H831252R2, H831711A4, H831714, H832351, H832771, H833680, H833856, H833995A1, H834116, H834409A1, H834456A1, H834456A4, H836687, H836972, H837942, H838118", "firm_fei_number": "2916710", "recalling_firm": "Varian Medical Systems Oncology Systems", "address_1": "911 Hansen Way", "city": "Palo Alto", "state": "CA", "postal_code": "94304-1028", "additional_info_contact": "Patricia Erwin, RAC\n650-424-5731", "reason_for_recall": "Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneously can result in a corrupted (but accessible) treatment plan record.", "root_cause_description": "Software design", "action": "On May 13, 2010, the firm issued letters to all its direct consignees, informing them of the affected products and providing instructions on the recall.\n\n***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***", "product_quantity": "2417 units***12-20-12 AMENDED TO: 49 units***", "distribution_pattern": "Nationwide and Worldwide", "openfda": { "k_number": [ "K132971", "K091179", "K982696", "K915691", "K211379", "K232400", "K171885", "K201444", "K982791", "K252304", "K012017", "K242992", "K211034", "K142108", "K041403", "K011246", "K041719", "K100056", "K160093", "K983343", "K180379", "K123263", "K051497", "K022036", "K991815", "K211841", "K260308", "K042269", "K100417", "K220783", "K082221", "K051941", "K100552", "K002312", "K201607", "K223279", "K151666", "K032724", "K210645", "K984532", "K150547", "K993675", 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