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.
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. Distribution: worldwide Quantity: 315 units Lot/code info: UDI/DI none, Serial Numbers: 152320, 105566, 152018, 152077, 152078, 152142, 152196, 152326, 152327, 152328, 152434, 152493, 152552, 152640, 152680, 152922, 152940, 152943, 153244, 153366, 153528, 153549, 153609, 153806, 154332, 154365, 151606, 151642, 151648, 151650, 151721, 151726, 151742, 151776, 151777, 151806, 151817, 151856, 151877, 151926, 151929, 151944, 151947, 152096, 152139, 152149, 152150, 152153, 152225, 152265, 152269, 152274, 152279, 152289, 152292, 152317, 152332, 152333, 152335, 152348, 152383, 152407, 152410, 152413, 152444, 152466, 152470, 152471, 152476, 152485, 152488, 152489, 152496, 152508, 152517, 152527, 152534, 152555, 152566, 152587, 152590, 152608, 152621, 152641, 152661, 152670, 152684, 152686, 152688, 152690, 152699, 152722, 152748, 152751, 152761, 152766, 152771, 152781, 152786, 152788, 152789, 152790, 152808, 152821, 152832, 152845, 152859, 152863, 152865, 152866, 152870, 152909, 152918, 152934, 152961, 153009, 153013, 153020, 153040, 153041, 153064, 153067, 153069, 153070, 153129, 153134, 153145, 153150, 153154, 153155, 153157, 153159, 153165, 153167, 153213, 153214, 153216, 153231, 153242, 153254, 153260, 153262, 153274, 153304, 153306, 153311, 153318, 153322, 153328, 153329, 153338, 153351, 153353, 153368, 153374, 153443, 153457, 153460, 153462, 153488, 153490, 153494, 153538, 153545, 153547, 153561, 153569, 153571, 153576, 153581, 153583, 153599, 153603, 153618, 153622, 153627, 153650, 153654, 153680, 153682, 153686, 153695, 153709, 153721,
Official record: FDA (Device enforcement) ↗
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