Elekta, Inc. recalls ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged

Hazard / Issue

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.

Issued by

FDA

Distribution: worldwide

Lot/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; UDI/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