—#165556

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

FDA product code: JAI — Couch, Radiation Therapy, Powered
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072898
Affected 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, 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.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The letter from Elekta dated May 2018 was issued via email 5/16/2018 and was flagged "URGENT IMPORTANT FIELD SAFETY NOTIFICATION. The letter identified the affected product, problem and actions to be taken.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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.

Timeline

Recall initiated: 2018-05-16
Terminated: 2020-10-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165556. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.