{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "74812", "product_res_number": "Z-0855-2009", "event_date_initiated": "2008-10-02", "event_date_posted": "2009-01-15", "recall_status": "Terminated", "event_date_terminated": "2010-11-27", "res_event_number": "50143", "product_code": "MUJ", "k_numbers": [ "K071873" ], "product_description": "Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA.\n\nIndicated for planning proton treatment of neoplasms of the eye.", "code_info": "Model number H48, serial numbers H480016, H480051, H480052, H480053, H480054, H480055, H480107, H480133, H480293, H480346, H480347, H480472, H480652, H480920, H481467, H481510, H481639, H481724, H481807, H481815, H481816, H481912, H481913, H481914, H481915, H482194, H482195, H482289, H482793, H482807, H483204, H483407, H484367, H484635, H484636, H484637, H484638, H484781, H484864, H485100, H485125, H485244, H485346, H485466, H485729, H486858, H486859, H486860, H486861, H486946, H486947, H486948, H487190, H487212, H487414, H487580, H487581, H487623, H487640, H487641, H487642, H487700, and H487757.", "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": "650-424-5731", "reason_for_recall": "When using the multiple static segment option, the device may alter dose delivery.", "root_cause_description": "Software design", "action": "An Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps on October 2, 2008. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm recommends that customers DO NOT USE the Multiple Static Segment (MSS) option in Varian Leaf Motion Calculator version 8.2.22. The firm also recommends setting the default delivery method for Varian Leaf Motion Calculator to Sliding Window. When using Eclipse 8.5, always follow the Safety Instructions found in chapter 2 of \"Eclipse External Beam Planning Instruction for Use\", P/N B501357R01A, March 2008. If customers believe a patient treatment has been affected by this issue, they should notify a Varian Service or Support person as soon as possible.", "product_quantity": "64 units", "distribution_pattern": "Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands.", "openfda": { "k_number": [ "K180308", "K170969", "K203469", "K231825", "K002132", "K994413", "K203766", "K201350", "K192065", "K202284", "K200569", "K032724", "K993895", "K002237", "K103515", "K010784", "K100417", "K013112", "K090808", "K190178", "K100092", "K990475", "K992864", "K151560", "K252863", "K133331", "K013661", "K103093", "K252784", "K092132", "K992303", "K151233", "K193109", "K022307", "K152393", "K915691", "K151887", "K092928", "K212274", "K090893", "K062967", "K002240", "K172163", "K201444", "K080929", "K080601", "K082642", "K250440", "K100552", "K190387", "K992434", "K250963", "K992753", "K123263", "K991237", "K120387", "K040688", "K101119", "K211881", "K042861", "K173635", "K242992", "K021268", "K190664", "K214081", "K090531", "K252109", "K091145", "K170750", "K220141", "K993675", "K203681", "K990071", "K071760", "K211379", "K222803", "K123152", "K082005", "K032345", "K113102", "K013673", "K222728", "K260207", "K240671", "K233236", "K002312", "K062032", "K102011", "K142108", "K192554", "K211841", "K161136", "K211034", "K200608", "K081281", "K200487", "K062514", "K121448", "K242822", "K090972", "K002147", "K080888", "K071938", "K201607", "K151380", "K030821", "K013535", "K100056", "K041403", "K162370", "K112723", "K993766", "K082606", "K063230", "K132816", "K150547", "K093391", "K031088", "K133247", "K050296", "K040474", "K151469", "K051497", "K071873", "K152488", "K091179", "K180289", "K041997", "K151369", "K180379", "K243057", "K083502", "K053584", "K181145", "K020971", "K133655", "K111311", "K210645", "K234068", "K011246", "K982821", "K143514", "K984196", "K091492", "K010682", "K102216", "K083264", "K984532", "K000922", "K132971", "K982696", "K141283", "K171885", "K140187", "K042739", "K131891", "K022961", "K983343", "K083414", "K223233", "K041971", "K170355", "K001295", "K052325", "K022741", "K012017", "K183037", "K991815", "K232799", "K253078", "K032456", "K252304", "K170086", "K974770", "K981678", "K031349", "K171536", "K141248", "K222312", "K253050", "K182665", "K061440", "K031281", "K151666", "K191384", "K063482", "K112776", "K193640", "K061097", "K223724", "K223279", "K211867", "K260750", "K112060", "K241318", "K101220", "K090182", "K103146", "K130617", "K993923", "K160093", "K051941", "K013644", "K252002", "K992762", "K112446", "K110730", "K012575", "K202789", "K173940", "K082221", "K022411", "K041719", "K032209", "K242748", "K141860", "K022036", "K061893", "K193459", "K241876", "K001700", "K091146", "K232479", "K242463", "K073020", "K240398", "K260308", "K081112", "K042269", "K230557", "K211511", "K143269", "K220783", "K232400", "K020027", "K093588", "K213438", "K250064", "K102915", "K101076", "K002509", "K151435", "K213787", "K242378", "K220582", "K141900", "K982791", "K120551", "K103246", "K120363", "K153368", "K123357", "K193381", "K253091", "K182888", "K131428", "K083672" ], "registration_number": [ "3002808157", "2939248", "3023344262", "3015232217", "3009302839", "3022719374", "3011716550", "3015777306", "3019543601", "3009090417", "8043933", "3022745617", "3003768277", "3025309924", "3044735888", "3000126629", "3018004899", "2030598", "3042177665", "3003094912", "3012039133", "3033527281", "2916710", "3003873069", "3004580128", "3025765259", "3004363352", "3007774465", "9611894", "3003586672", "3014425747", "2183553", "3009077524", "3009529630", "3013410552", "3006579682", "3006894636", "3030564015", "3003418325", "3004526608", "3016686005", "3010123525", "3005136058", "3019834893", "3003793371", "3007037519", "9617978", "3004977335", "3014873236", "3004608878", "3004555507", "3010034862", "1038814", "3007791541", "3016602874", "3008156050", "1651102", "2434141", "3004561814" ], "fei_number": [ "3002808157", "2939248", "3023344262", "3002807741", "3015232217", "3009302839", "1000518731", "3022719374", "3011716550", "3015777306", "3019543601", "3009090417", "3022745617", "3044735888", "3025309924", "3008581796", "3000126629", "3002807880", "3018004899", "3042177665", "3003094912", "3012039133", "3002619595", "3033527281", "2916710", "3003873069", "3004580128", "3025765259", "3004363352", "3007774465", "3003586672", "3014425747", "2183553", "3009077524", "3009529630", "3013410552", "3006579682", "3006894636", "3030564015", "3003418325", "3004526608", "3016686005", "3010123525", "3005136058", "3019834893", "3003793371", "3007037519", "3002802883", "3004977335", "3014873236", "3004608878", "3004555507", "3010034862", "1038814", "3007791541", "3016602874", "3008156050", "2434141", "3004561814" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }