{ "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": "94517", "product_res_number": "Z-0821-2011", "event_date_initiated": "2010-07-20", "event_date_posted": "2010-12-28", "recall_status": "Terminated", "event_date_terminated": "2011-07-18", "res_event_number": "56774", "product_code": "IYE", "k_numbers": [ "K072916" ], "product_description": "Varian brand Trilogy System with RapidArc, Model Numbers: \nH14, H26, H27, H29; Distributed and Manufactured by: \nVarian Medical Systems Inc., Palo Alto, CA", "code_info": "H140025,H140753,H140845,H140896,H272157 ,H272963 ,H291040 ,H291187 ,H293443 ,H293691,H140038 ,H140769,H140846 ,H140901 ,H272158 ,H272981,H291048,H291190 ,H293447 ,H293696,H140045 ,H140772 ,H140848 ,H140902 ,H272165 ,H272982,H291050 ,H291206 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\t,H294128 \t,H294224 \t,H294326 \t,H294404 \t,H294494 \t,H294554 \t,H294645 \t,H294726 \t,H294827  ,H293993 \t,H294130 \t,H294227 \t,H294329 \t,H294406 \t,H294497 \t,H294556 \t,H294646 \t,H294727 \t,H294829  ,H294002 \t,H294133 \t,H294232 \t,H294330 \t,H294409 \t,H294498 \t,H294557 \t,H294652 \t,H294728,H294004 \t,H294134 \t,H294238 \t,H294331 \t,H294414 \t,H294499 \t,H294565 \t,H294654 \t,H294729", "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": "Dave Hall \n650-424-5731", "reason_for_recall": "The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option.", "root_cause_description": "Software design", "action": "Varian issued Urgent Medical Device Correction letters dated July 20, 2010 to its direct consignees, informing them of the affected product and providing instructions on the actions to be taken. These instruction include: if the unit does not display \"RapidArc\" or \"VMAT\" under Treatment Type during dose delivery, discontinue use of the device and call Varian service.\nVarian Service Help Desk can be contacted at 1-888-827-4265.", "distribution_pattern": "Worldwide Distributiuon: Throughout the US, and the countries of Australia, Canada, China, Japan, and New Zealand, and in the regions of North and Latin America, Europe, and South East Asia.", "openfda": { "k_number": [ "K972804", "K102671", "K930182", "K962080", "K152321", "K130678", "K052920", "K202747", "K020320", "K926008", "K943464", "K090044", "K932598", "K913612", "K223229", "K924495", "K051932", "K960510", "K210894", "K031634", "K223839", "K020294", "K963451", "K092845", "K173926", "K970586", "K951808", "K162862", "K922276", "K961170", "K003330", "K033343", "K122888", "K112286", "K970137", "K941118", "K182138", "K935411", "K140823", "K950866", "K250392", "K220539", "K871214", "K933614", "K181218", "K982463", 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