{ "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": "43208", "product_res_number": "Z-0393-06", "event_date_initiated": "2005-11-23", "event_date_posted": "2006-01-18", "recall_status": "Terminated", "event_date_terminated": "2006-07-05", "res_event_number": "34160", "product_code": "IWB", "k_numbers": [ "K010975", "K023052", "K932501" ], "product_description": "Varian brand Radiation Therapy Linear Accelerator VARiS;\n\nVARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC);\n\nProduct Number 83 (used with Product Number 53);\nProduct Number 48 (used with Product Number 53);\nProduct Number 77 (used with Product Number 53);\n\n\nProduct is distributed by Varian Medical Systems, 911 Hansen Way, Palo Alto, CA 94304", "code_info": "H530338, H531026, H532001, H532024, H541335, H532011, H531018, H530104, H532027, H530309, H530321, H530323, H531034, H531995, H530204, H541198, H531038, H530427, H532036, H530313, H530250, H532025, H530064, H530009, H530093, H530311, H530042, H530231, H530316, H530084, H530065, H530022, H530029, H530340, H530302, H532023, H530059, H531037, H530396, H530080, H532038, H530333, H530408, H531024, H530032, H530025, H530414, H530051, H530052, H530310, H533006, H530324, H530419, H530056, H531040, H531043, H531033, H530086, H532028, H532010, H530433, H532035, H531044, H532020, H531039, H535018, H531017, H530078, H532002, H530406, H532019, H530334, H531002, H530019, H532031, H530107, H530066, H530075, H530417, H532015, H533001, H530001, H530018, H530033, H531036, H530402, H534223, H530017, H530011, H530434, H533020, H530074, H530428, H530339, H530425, H530031, H532026, H531031, H531001, H533035, H530050, H530024, H530439, H531470, H531487, H532032, H534015, H530039, H531838, H532022, H533018, H530437, H530030, H532006, H533008, H535009, H533015, H534021, H534022, H534032, H530061, H532037, H530028, H531010, H531028, H535012, H532039, H530013, H530073, H530330, H533030, H534004, H534040, H530085, H533027, H534036, H532005, H530430, H530435, H531029, H530023, H530035, H530036, H530037, H530038, H530045, H530049, H530063, H530126, H530401, H530409, H530410, H530429, H530441, H531020, H531021, H532042, H533036, H535001, H535008, H531035, H531041, H532014, H533004, H535003, H535004, H530014, H533014, H530012, H530021, H530337, H531023, H533037, H530004, H530008, H530027, H530047, H530055, H530068M, H530068R1, H530072, H531008, H532013, H533032, H530087, H533028, H533029, H534026, H535002, H535013, H531025, H532021, H534020, H530081, H532007, H530057, H530076, H533043, H530043, H530405, H531042, H531345, H532004, H532016, H530052, H530104, H530402, H530427, H531044, H530034, H530218, H535015, H530048, H530423, H530005, H530046, H532029, H530319, H535005", "firm_fei_number": "2916710", "recalling_firm": "Varian Medical Systems Inc", "address_1": "911 Hansen Way", "city": "Palo Alto", "state": "CA", "postal_code": "94304-1038", "additional_info_contact": "Dale Reynolds\n650-424-5877", "reason_for_recall": "The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.", "root_cause_description": "Other", "action": "On 11/23/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.", "distribution_pattern": "Worldwide to 219 accounts. U.S. States: AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV. 118 accounts Foreign consignees include Netherlands, Thailand, Taiwan, R.O.C., Sweden, Spain, South Korea, South Africa, Slovenia, Singapore, Saudi Arabia, Russian Fed., Portugal, Poland, Philippines, Mexico, Malaysia, Japan, Italy, Israel, India, Hong Kong, Germany, France, Finland, Egypt, Denmark, Czech Republic, China, Canada, Brazil, Belgium, Austria, and Australia.", "openfda": { "k_number": [ "K000478", "K133565", "K984328", "K924849", "K120811", "K925133", "K131777", "K102533", "K180571", "K151159", "K173789", "K150191", "K061941", "K250391", "K200050", "K970647", "K222047", "K060314", "K827583", "K053485", "K092083", "K001006", "K894165", "K142219", "K860849", "K190844", "K061540", "K041125", "K063512", "K160440", "K914808", "K051022", "K151561", "K964606", "K232854", "K863180", "K983917", "K960892", "K203146", "K780948", "K850543", "K173791", "K172706", "K203250", "K871215", "K973441", "K984563", "K912250" ], "registration_number": [ "1038814", "9617016", "3015621321", "3020999824", "3015620182", "3015232217", "3006946288", "3014273653", "3005136058", "2939248" ], "fei_number": [ "1038814", "3002806900", "3015621321", "3020999824", "3015620182", "3015232217", "3006946288", "3014273653", "3005136058", "2939248" ], "device_name": "System, Radiation Therapy, Radionuclide", "medical_specialty_description": "Radiology", "regulation_number": "892.5750", "device_class": "2" } } ] }