Elekta, Inc. recalls HexaPOD evo RT Couch Top (also known as HexaPOD evo Module),

Hazard / Issue

Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: UDI 04056719001698. Serial numbers: 42380, 42384, 42626, 03005, 42009, 42012, 42013, 42062, 42068, 42106, 42107, 42126, 42153, 42217, 42224, 42292, 42293, 42301, 42435, 42491, 42496, 42517, 42615, 42620, 42690, 42691, 42731, 03019, 42092, 42222, 42356, 42382, 42601, 42649, 42658, 42743, 42289, 03000, 42311, 42586, 42471, 03017, 03022, 42057, 42058, 42129, 42159, 42187, 42279, 02982, 02986, 02991, 42004, 42113, 42178, 42189, 42202, 42207, 42209, 42212, 42213, 42216, 42220, 42416, 42417, 42418, 42419, 42420, 42463, 42652, 42704, 42706, 02987, 03008, 03018, 42000, 42008, 42032, 42048, 42064, 42070, 42074, 42084, 42102, 42115, 42118, 42134, 42137, 42142, 42145, 42146, 42152, 42174, 42177, 42237, 42312, 42329, 42330, 42341, 42363, 42369, 42371, 42375, 42383, 42394, 42409, 42446, 42450, 42453, 42457, 42464, 42474, 42501, 42509, 42519, 42523, 42524, 42550, 42553, 42587, 42611, 42612, 42643, 42647, 42662, 42674, 42681, 42694, 42721, 42722, 42069, 03029, 42036, 42709, 42710, 42139, 42162, 42591, 42592, 42421, 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42719, 42081, 42090, 42093, 42095, 42110, 42114, 42133, 42181, 42332, 42671, 42576, 02580, 02977, 03016, 42116, 42396, 42532, 42689, 42010, 42073, 42295, 42296, 42661, 42753, 42176, 42164, 42588, 42589, 42590, 42599, 02963, 03028, 42373, 02976, 02979, 02988, 03015, 03021, 03027, 42022, 42034, 42038, 42041, 42088, 42104, 42348, 42352, 42372, 42452, 42468, 42238, 42346, 42302, 42547, 42560, 42412, 42490, 42432, 42433, 42659, 42006, 42024, 42060, 42082, 42194, 42232, 42263, 42318, 42342, 42344, 42351, 42368, 42395, 42534, 42628, 42642, 42673, 42688, 42693, 42702, 42199, 42573, 42684, 42170, 02985, 42078, 42138, 42158, 42161, 42188, 42215, 42242, 42275, 42308, 42327, 42370, 42414, 42425, 42445, 42470, 03032, 42120, 42313, 42533, 42641, 42056, 42306, 42530, 42665, 42667, 42707, 02964, 02969, 02972, 02984, 42290, 42495, 42563, 42607, 42616, 42629, 42668, 42675, 42725, 42739, 02966, 02968, 02970, 02971, 02973, 02974, 02981, 02990, 02992, 02996, 03001, 03007, 03012, 03013, 03014, 03025, 03026, 42014, 42017, 42020, 42023, 42030, 42040, 42043, 42044, 42045, 42046, 42052, 42066, 42067, 42071, 42072, 42096, 42097, 42099, 42100, 42111, 42112, 42122, 42123, 42125, 42130, 42131, 42136, 42141, 42143, 42144, 42148, 42149, 42154, 42160, 42171, 42172, 42175, 42190, 42191, 42203, 42205, 42206, 42208, 42211, 42218, 42225, 42228, 42229, 42230, 42233, 42241, 42244, 42255, 42257, 42258, 42274, 42277, 42278, 42280, 42285, 42287, 42288, 42294, 42297, 42299, 42303, 42307, 42309, 42310, 42315, 42320, 42322, 42323, 42324, 42328, 42335, 42339, 42340, 42345, 42357, 42359, 42390, 42391, 42393, 42407, 42408, 42411, 42423, 42426, 42429, 42431, 42437, 42438, 42448, 42456, 42467, 42469, 42473, 42475, 42479, 42486, 42486, 42487, 42489, 42492, 42497, 42500, 42506, 42510, 42515, 42528, 42529, 42540, 42541, 42542, 42543, 42544, 42548, 42552, 42556, 42558, 42559, 42566, 42572, 42578, 42579, 42583, 42585, 42605, 42606, 42613, 42614, 42619, 42621, 42632, 42633, 42634, 42639, 42640, 42651, 42653, 42654, 42655, 42656, 42657, 42686, 42700, 42703, 42714, 42717, 42720, 42727, 42128, 42593, 42617, and 42625.