{ "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": "203795", "product_res_number": "Z-0445-2024", "event_date_initiated": "2023-10-25", "event_date_posted": "2023-12-01", "recall_status": "Open, Classified", "res_event_number": "93264", "product_code": "IYE", "k_numbers": [ "K210500" ], "product_description": "ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear", "code_info": "UDI/DI 05060191071529, Serial Numbers: 153396, 153671, 109003, 153383, 153384, 153055, 153980, 154001, 154002, 154003, 154004, 154272, 153104, 153188, 153243, 153745, 153836, 153872, 153876, 154123, 154148, 154199, 154250, 154260, 154267, 154269, 154449, 154498, 154550, 152951, 153140, 153525, 153526, 153532, 154218, 153621, 153951, 153949, 154028, 154548, 154239, 154262, 153413, 153829, 154163, 154101, 152777, 153037, 153142, 153144, 153177, 153186, 153187, 153189, 153277, 153364, 153399, 153425, 153426, 153471, 153510, 153537, 153578, 153625, 153661, 153752, 153762, 153782, 153797, 153808, 153816, 153847, 153858, 153950, 153986, 153997, 154046, 154070, 154084, 154085, 154127, 154178, 154202, 154217, 154280, 154372, 154374, 154381; \n\nUDI/DI 05060191071574, Serial Numbers: 153722, 109005, 109007, 153003, 153008, 153314, 153337, 153427, 153428, 153482, 153649, 153900, 154023, 154024, 154050, 154087, 154299, 154300, 153248, 153699, 154043, 154395, 154435, 154179, 154131, 153658, 153830, 154221, 154473, 153976, 153128, 153608, 154505, 154531, 154325, 153406, 153601, 153607, 153667, 153720, 153723, 153751, 153839, 153862, 153940, 153985, 154055, 154076, 154140, 154149, 154283, 154293, 154296, 154375, 154421, 154398, 152843, 152912, 153778, 153893, 153894, 154327, 154328, 154408, 153379, 153381, 152917, 153113, 153452, 153453, 154077, 154198, 154258, 154450, 153835, 153023, 153025, 153095, 153106, 153180, 153249, 153279, 153281, 153320, 153356, 153359, 153380, 153385, 153470, 153619, 153656, 153702, 153706, 153711, 153765, 153791, 153801, 154027, 154057, 154128, 154216, 154301, 154382, 154383, 154386, 154390, 154470, 154479, 154497, 154502, 154562, 153628, 154133, 154167, 154226, 154369, 153715, 153151, 153232, 153315, 153432, 153455, 153524, 153539, 153846, 153857, 153929, 154016, 154021, 154031, 154032, 154142, 154187, 154214, 154225, 154233, 154257, 154285, 154320, 154400, 154402, 154412, 154444, 154462, 154464, 154509, 154541, 154284, 153239, 154279, 154500, 153739, 153412, 153433, 153485, 153860, 153936, 153978, 153996, 154012, 154013, 154174, 154236, 154416, 153594, 153689, 153776, 153902, 153905, 153965, 153998, 154040, 154158, 154172, 154197, 154200, 154222, 154254, 154436, 154481, 154291, 154298, 154410, 153287, 153459, 153612, 153647, 153657, 154022, 154430, 154348, 153563, 153564, 153437, 153110, 153222, 153454, 153766, 153775, 154150, 154151, 154152, 154334, 154335, 154336, 154337, 154338, 154511, 109004, 153130, 153163, 154039, 153245, 153589, 153637, 153837, 153932, 154038, 154442, 153185, 154251, 154252, 154268, 154271, 153611, 153662, 152960, 153913, 153916, 153959, 153968, 153513, 153316, 153679, 153417, 154379, 154438, 153181, 153467, 153562, 154124, 154333, 154373, 154503, 154513, 154544, 152995, 154219, 154529, 153517, 153642, 153713, 153838, 153975, 154212, 154276, 153438, 154406, 153250, 153479, 153861, 154112, 154274, 154275, 154445, 154456, 154490, 152944, 153096, 153097, 153171, 153225, 153307, 153369, 153418, 153439, 153818, 153833, 153851, 154059, 154063, 154176, 154207, 154227, 154331, 154346, 154347, 154350, 154351, 154352, 154354, 154358, 154360, 154361, 154362, 154458, 154476, 154496, 152948, 152954, 153044, 153278, 153295, 153312, 153340, 153373, 153376, 153435, 153447, 153456, 153466, 153468, 153486, 153487, 153492, 153585, 153614, 153624, 153638, 153664, 153687, 153705, 153716, 153796, 153832, 153843, 153890, 153892, 153897, 153903, 153908, 153941, 153990, 153991, 154017, 154020, 154066, 154083, 154105, 154111, 154137, 154170, 154171, 154173, 154184, 154185, 154190, 154193, 154195, 154243, 154245, 154322, 154323, 154339, 154340, 154388, 154413, 154426, 154427, 154431, 154518, 154559, 154349", "firm_fei_number": "1037831", "recalling_firm": "Elekta, Inc.", "address_1": "400 Perimeter Center Ter NE Ste 50 400 Perimeter Center Ter NE", "address_2": "Ste 50", "city": "Atlanta", "state": "GA", "postal_code": "30346-1227", "additional_info_contact": "770-670-2422", "reason_for_recall": "Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.", "root_cause_description": "Under Investigation by firm", "action": "Elekta released Field Safety Notice to its consignees on the 10/25/2023 via email. The notice explained the issue, potential risk, and provides information for the safe use of the instrument until Elekta Field Service Representatives can perform the correction.", "product_quantity": "451 units", "distribution_pattern": "worldwide", "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", "K253962", "K973889", "K960834", "K873398", "K100264", "K092041", "K071531", "K991319", "K981597", "K900434", "K032762", "K120233", "K970291", "K926321", "K102237", "K991133", "K142617", "K160209", "K142431", 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