HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT sy...
FDA Device Recall #Z-2535-2018 — Class II — May 16, 2018
Recall Summary
| Recall Number | Z-2535-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 16, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Elekta, Inc. |
| Location | Atlanta, GA |
| Product Type | Devices |
| Quantity | 725 devices |
Product Description
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
Reason for Recall
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.
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.
Lot / 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.
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.