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
Check against the official notice below — it lists the full affected range.
Elekta, Inc. is recalling the HexaPOD evo RT Couch Top (also called HexaPOD evo Module), a component used to position patients during radiation therapy. The device may end up in a tilted state after completing a 6D workflow if it is then moved to the position used for 3D treatments, which could result in incorrect patient positioning. A total of 725 devices have been distributed worldwide, including throughout the United States and to numerous countries internationally.
The recall affects devices with UDI 04056719001698 and specific serial numbers listed in the recall notice. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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, Isr Quantity: 725 devices 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, 4
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.