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Recall Observatory FDA recall evidence

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

May 16, 2018

Class II

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

    reason.no_named_rule · v1.0.0

    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.