Device product
HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
Z-2535-2018
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 80471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 725 devices
- Official record key
device-enforcement:Z-2535-2018
Official wording
Reason: 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.
Code information: 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, 42669, 42011, 03006, 42007, 42109, 42173, 42193, 42282, 42392, 42405, 42427, 42428, 42504, 42535, 42602, 42603, 42644, 42680, 42685, 02998, 03003, 03033, 42015, 42053, 42053, 42065, 42085, 42091, 42094, 42105, 42124, 42198, 42219, 42271, 42334, 42386, 42388, 42397, 42449, 42507, 42574, 42618, 42635, 42687, 42692, 03024, 42121, 42338, 42377, 42412, 42545, 42546, 42627, 42444, 42498, 03020, 42027, 42061, 42075, 42079, 42214, 42248, 42286, 42305, 42314, 42413, 42455, 42481, 42482, 42502, 42505, 42518, 42520, 42522, 42527, 42561, 42564, 42571, 42577, 42584, 42598, 42609, 42630, 42637, 42638, 42670, 42699, 42600, 42604, 42682, 42192, 42381, 02960, 02961, 02962, 02995, 03030, 42002, 42021, 42025, 42033, 42035, 42089, 42127, 42151, 42155, 42200, 42204, 42221, 42239, 42247, 42281, 42325, 42326, 42360, 42361, 42365, 42366, 42424, 42454, 42476, 42477, 42478, 42484, 42485, 42494, 42499, 42526, 42531, 42555, 42575, 42678, 42724, 42733, 42734, 02993, 02997, 03002, 03004, 03031, 42001, 42016, 42028, 42029, 42037, 42042, 42047, 42049, 42050, 42051, 42054, 42055, 42063, 42077, 42080, 42083, 42087, 42101, 42103, 42117, 42140, 42147, 42150, 42156, 42157, 42163, 42165, 42166, 42169, 42179, 42180, 42182, 42183, 42186, 42195, 42196, 42197, 42223, 42227, 42231, 42234, 42235, 42236, 42240, 42243, 42245, 42249, 42250, 42251, 42253, 42254, 42256, 42260, 42261, 42262, 42264, 42265, 42266, 42267, 42268, 42269, 42270, 42272, 42276, 42291, 42298, 42300, 42304, 42331, 42333, 42336, 42337, 42347, 42349, 42350, 42353, 42354, 42355, 42358, 42362, 42378, 42379, 42385, 42389, 42398, 42399, 42400, 42401, 42402, 42403, 42404, 42406, 42436, 42439, 42440, 42441, 42442, 42443, 42458, 42459, 42460, 42472, 42483, 42493, 42511, 42512, 42536, 42537, 42538, 42539, 42554, 42557, 42562, 42565, 42567, 42568, 42569, 42570, 42580, 42581, 42582, 42597, 42610, 42660, 42663, 42672, 42696, 42697, 42698, 42701, 42708, 42226, 42018, 42135, 42185, 42252, 42273, 42284, 42364, 42367, 42374, 42488, 42618, 42648, 42677, 42525, 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.
Distribution pattern: Worldwide Distribution - US Distribution of the device was made nationwide. There was government distribution but no military distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Democratic People's Republic of Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Sweden, Thailand, Turkey, United Kingdom, and Viet Nam.
Derived failure modes
-
Unknown
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.