{ "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": "105415", "product_res_number": "Z-0370-2012", "event_date_initiated": "2011-10-31", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2014-06-06", "res_event_number": "60441", "product_code": "MUJ", "k_numbers": [ "K091492" ], "product_description": "Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An \nEclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart\nmodule), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA.\n\nThe Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.", "code_info": "CODES: All codes from H480005 through H48C896", "firm_fei_number": "2916710", "recalling_firm": "Varian Medical Systems, Inc. Oncology Systems", "address_1": "911 Hansen Way", "city": "Palo Alto", "state": "CA", "postal_code": "94304-1028", "additional_info_contact": "Peter J. Coronado\n650-424-5731", "reason_for_recall": "An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point\nin RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction\nin Eclipse.", "root_cause_description": "Device Design", "action": "Varian Medical Systems sent an \"URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE\" dated October 31, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Varian has corrected the issue and will contact customers to schedule installation of the corrected version of the system. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice.\n\n.", "distribution_pattern": "Worldwide Distribution.", "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", "K133331", "K112723", "K081281", "K013112", "K211511", "K253078", "K994413", "K202789", "K013673", "K992762", "K090972", "K240671", "K182665", "K083264", "K133247", "K041971", "K192065", "K010682", "K022411", "K090531", "K151560", "K170086", "K090182", "K151887", "K002147", "K172163", "K252109", "K203469", "K032345", "K190664", "K063482", "K002509", "K080888", "K133655", "K111311", "K151380", "K213438", "K162370", "K220582", "K101076", "K991237", "K061097", "K200569", "K213787", "K250963", "K091146", "K193109", "K974770", "K042739", "K202284", "K092132", "K112060", "K081112", "K141283", "K091492", "K113102", "K022307", "K102216", "K042861", "K063230", "K020027", "K170750", "K061440", "K120363", "K200608", "K220141", "K241318", "K012575", "K123152", "K242748", "K232799", "K252002", "K022741", "K031349", "K062967", "K121448", "K152393", "K141860", "K173940", "K992864", "K013644", "K222312", "K100092", "K203766", "K242378", "K193640", "K252863", "K243057", "K222803", "K990475", "K032456", "K040474", "K253050", "K993766", "K140187", "K161136", "K131891", "K141900", "K200487", "K050296", "K103093", "K071938", "K082005", "K083414", "K203681", "K001295", "K993923", "K182888", "K021268", "K123357", "K993895", "K151435", "K151369", "K233236", "K093588", "K092928", "K101220", "K080601", "K141248", "K214081", "K240398", "K013661", "K061893", "K211881", "K211867", "K990071", "K071760", "K002132", "K242822", "K143514", "K120387", "K250064", "K082642", "K223724", "K231825", "K222728", "K992434", "K170969", "K001700", "K062514", "K153368", "K982821", "K080929", "K071873", "K151469", "K031088", "K260207", "K053584", "K010784", "K191384", "K992753", "K093391", "K170355", "K030821", "K041997", "K130617", "K151233", "K192554", "K252784", "K132816", "K131428", "K013535", "K171536", "K031281", "K083672", "K110730", "K002237", "K103246", "K040688", "K193381", "K103146", "K082606", "K190178", "K052325", "K223233", "K260750", "K984196", "K212274", "K020971", "K022961", "K032209", "K181145", "K102915", "K981678", "K183037", "K230557", "K992303", "K112446", "K120551", "K201350", "K241876", "K102011", "K143269", "K090808", "K190387", "K002240", "K112776", "K234068", "K250440", "K180308", "K232479", "K083502", "K090893", "K000922", "K242463", "K091145", "K173635", "K101119", "K103515", "K073020", "K180289", "K062032", "K253091", "K193459", "K152488" ], "registration_number": [ "1038814", "2030598", "8043933", "3019834893", "3012039133", "3014425747", "3016686005", "3003873069", "3009529630", "2183553", "3004555507", "3011716550", "3025309924", "3003418325", "3000126629", "3007791541", "9617978", "3044735888", "1651102", "3002808157", "3008156050", "3003586672", "3003793371", "3009090417", "3004363352", "3005136058", "3014873236", "3025765259", "3006579682", "3019543601", "3006894636", "3015777306", "3004561814", "3010034862", "3013410552", "3009302839", "9611894", "3010123525", "3003094912", "3007037519", "3004580128", "3022719374", "2916710", "3022745617", "3018004899", "3004608878", "2939248", "3004977335", "3030564015", "3007774465", "3009077524", "3016602874", "3042177665", "3015232217", "3023344262", "3033527281", "2434141", "3003768277", "3004526608" ], "fei_number": [ "1038814", "3019834893", "3012039133", "3014425747", "3016686005", "3003873069", "3002619595", "3009529630", "2183553", "3004555507", "3011716550", "3025309924", "3003418325", "3000126629", "3007791541", "3044735888", "3002807741", "3002808157", "3008156050", "3003586672", "3003793371", "3009090417", "3004363352", "3005136058", "3014873236", "3002807880", "3025765259", "3006579682", "3019543601", "3006894636", "3015777306", "3002802883", "3004561814", "3010034862", "3013410552", "3009302839", "3003094912", "3010123525", "3007037519", "3004580128", "3022719374", "2916710", "3022745617", "3018004899", "3004608878", "2939248", "3004977335", "3030564015", "3007774465", "1000518731", "3009077524", "3016602874", "3008581796", "3042177665", "3015232217", "3023344262", "3033527281", "2434141", "3004526608" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }