ELEKTA LIMITED Elekta Synergy recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 05060191071505, Serial Numbers: 154549, 151917, 151963, 152072, 152081, 152131, 152382, 151838, 152318, 152807, 151951, 152416, 153147, 153148, 153963, 151821, 151845, 151940, 152160, 152162, 152164, 152389, 152393, 152394, 152634, 152635, 152636, 152664, 152665, 152725, 152992, 151850, 151920, 152082, 152089, 152111, 152546, 152548, 152299, 152403, 152503, 152676, 152950, 151857, 151690, 151744, 151745, 151766, 151831, 151859, 151900, 151950, 152046, 152137, 152194, 152202, 152216, 152258, 152276, 152376, 152390, 152391, 152399, 152414, 152430, 152431, 152513, 152521, 152557, 152576, 152645, 152647, 152712, 152719, 152740, 152743, 153093, 153115, 153126, 153258, 153299, 153475, 153554, 153804, 153911, 154415, 151852, 151894, 151971, 152185, 152241, 152297, 152422, 152429, 152584, 152616, 152628, 152631, 152681, 152698, 152746, 152747, 152770, 152804, 152811, 152812, 152813, 152985, 153256, 153286, 153546, 152014, 152208, 153952, 152883, 152714, 154342, 152724, 151366, 152047, 152074, 152075, 152133, 152197, 152290, 152291, 152395, 152462, 152465, 152646, 152682, 152945, 153476, 153620, 153640, 154071, 151815, 152157, 152602, 152726, 152729, 152750, 152763, 152806, 152987, 151771, 151905, 154255, 152482, 152580, 152582, 152583, 152586, 152639, 152735, 152738, 152785, 152797, 152850, 153124, 153290, 152119, 152603, 152942, 152744, 153122, 152452, 151972, 152016, 152038, 152052, 152251, 152267, 152287, 152523, 152572, 152578, 152605, 152606, 152611, 152826, 152880, 152924, 152925, 152931, 153162, 153259, 153292, 153293, 153520, 153669, 153365, 154483, 151973, 152545, 152060, 151895, 152102, 152190, 151775, 151830, 151843, 151871, 151893, 151985, 151987, 152655, 152656, 152657, 152658, 152720, 153757, 153758, 153763, 153774, 153777, 151492, 152201, 152653, 151033, 151176, 151398, 151416, 151517, 151640, 151683, 151700, 151710, 151736, 151759, 151791, 151810, 151860, 151885, 151892, 151902, 151954, 151956, 151989, 152043, 152098, 152116, 152123, 152214, 152232, 152331, 152475, 152530, 152559, 152703, 152767, 152815, 153045, 153086, 153867, 154515; UDI/DI: 05060191071550, Serial Numbers: 152008, 153854, 153863, 153954, 153995, 109002, 152007, 152369, 152379, 152619, 152695, 152696, 152896, 152897, 152905, 152926, 153007, 153012, 153014, 153024, 153152, 153276, 153033, 153220, 151836, 153449, 154138, 151868, 152188, 152533, 152093, 152363, 152472, 154042, 152005, 152056, 152259, 152272, 152354, 152500, 152689, 152796, 153022, 153943, 154263, 154384, 153728, 151928, 152124, 152166, 152242, 152244, 152651, 151673, 153038, 151403, 151624, 151663, 151948, 151970, 151979, 152010, 152020, 152024, 152090, 152095, 152145, 152178, 152203, 152253, 152268, 152296, 152334, 152385, 152408, 152411, 152415, 152449, 152453, 152474, 152487, 152516, 152529, 152532, 152560, 152568, 152588, 152594, 152610, 152666, 152671, 152685, 152693, 152704, 152773, 152774, 152775, 152776, 152780, 152810, 152814, 152820, 152823, 152837, 152856, 152857, 152872, 152876, 152877, 152884, 152886, 152910, 152911, 152914, 152932, 152941, 152966, 152986, 153026, 153027, 153063, 153073, 153078, 153079, 153083, 153105, 153131, 153132, 153139, 153146, 153158, 153191, 153196, 153207, 153261, 153263, 153264, 153271, 153272, 153273, 153275, 153280, 153305, 153309, 153317, 153390, 153391, 153392, 153393, 153394, 153395, 153405, 153419, 153420, 153421, 153422, 153431, 153458, 153469, 153477, 153480, 153484, 153502, 153515, 153519, 153541, 153555, 153565, 153588, 153590, 153591, 153592, 153613, 153630, 153643, 153648, 153653, 153659, 153663, 153665, 153700, 153707, 153712, 153717, 153729, 153734, 153735, 153736, 153754, 153764, 153767, 153787, 153800, 153810, 153815, 153817, 153823, 153873, 153912, 153928, 153942, 153947, 153958, 153974, 153988, 153999, 154007, 154036, 154054, 154068, 154073, 154080, 154086, 154097, 154103, 154106, 154177, 154183, 154248, 154281, 154288, 154294, 154304, 154315, 154377, 154391, 154393, 154506, 152239, 152737, 154433, 153899, 153733, 153740, 153744, 153793, 153914, 153984, 151787, 151853, 151854, 152461, 152569, 152574, 153099, 151796, 152435, 152441, 151841, 152199, 152852, 153938, 153970, 154273, 154368, 151846, 151890, 151914, 151998, 152034, 152035, 152069, 152092, 152105, 152125, 152138, 152147, 152173, 152230, 152235, 152236, 152245, 152284, 152309, 152340, 152360, 152387, 152409, 152417, 152418, 152515, 152561, 152562, 152563, 152565, 152575, 152630, 152716, 152855, 152874, 152875, 152879, 152882, 152973, 152976, 152978, 152999, 153034, 153062, 153094, 153182, 153283, 153387, 153404, 153489, 153559, 153580, 153639, 153781, 153786, 153831, 153848, 153856, 153957, 154104, 154129, 154316, 154507, 153172, 153616, 152779, 153575, 153742, 151943, 151996, 152042, 152066, 152114, 152141, 152165, 152189, 152224, 152254, 152256, 152264, 152266, 152313, 152443, 152492, 152524, 152567, 152591, 152607, 152648, 152844, 152900, 152908, 152923, 153065, 153169, 153313, 153533, 153567, 153635, 153755, 153853, 154259, 151932, 151930, 152002, 152054, 152100, 152109, 152215, 152247, 152322, 152343, 152507, 152613, 152757, 152906, 153002, 153011, 153028, 153029, 153160, 153195, 153215, 153251, 153331, 153424, 153556, 153566, 153606, 153641, 153812, 153821, 153944, 153966, 154044, 154107, 151596, 151819, 151862, 151870, 152032, 152087, 152104, 152106, 152180, 152204, 152243, 152260, 152275, 152294, 152304, 152324, 152345, 152351, 152357, 152494, 152495, 152528, 152544, 152550, 152551, 152553, 152577, 152624, 152637, 152667, 152727, 152758, 152759, 152762, 152800, 152805, 152830, 152892, 152893, 152938, 152953, 152980, 152991, 152998, 153018, 153039, 153051, 153056, 153057, 153058, 153074, 153075, 153088, 153100, 153101, 153108, 153109, 153176, 153197, 153201, 153203, 153210, 153223, 153224, 153233, 153235, 153238, 153265, 153268, 153269, 153301, 153302, 153341, 153344, 153345, 153347, 153463, 153473, 153478, 153495, 153497, 153500, 153501, 153504, 153570, 153572, 153574, 153634, 153645, 153666, 153672, 153684, 153694, 153710, 153785, 153814, 153874, 153875, 153882, 153883, 153917, 153923, 153953, 153964, 153973, 154009, 154157, 154160, 154194, 154196, 154215, 154220, 154223, 154241, 154261, 154326, 154359, 154437, 154441, 151879, 151974, 152206, 152851, 152073, 152595, 152710, 152711, 152733, 152861, 152975, 153087, 153577, 153651, 151656, 152015, 152947, 153509, 152295, 152311, 152428, 152458, 152622, 152623, 152632, 152633, 152697, 152741, 152868, 152887, 152949, 152983, 153081, 153082, 153725, 153726, 153780, 153849, 153880, 154030, 154141, 154344, 151966, 151662, 152535, 152915, 153348, 154203, 152871, 152988, 152989, 153116, 153117, 153209, 153221, 153247, 153252, 152048, 152050, 152713, 153355, 154371, 151800, 151835, 152323, 152903, 153543, 153604, 153691, 154000, 154210, 152336, 152625, 152626, 152700, 152701, 152234, 152705, 153208, 153219, 154540, 152346, 152981, 153859, 154095, 151833, 151899, 151899, 152152, 152172, 152281, 152426, 152793, 153016, 153153, 153202, 153378, 153416, 153530, 153584, 153696, 153697, 153361, 152847, 151990, 152085, 152099, 152108, 152122, 152212, 152227, 152240, 152273, 152282, 152300, 152442, 152445, 152447, 152459, 152464, 152525, 152537, 152540, 152541, 152547, 152660, 152795, 152827, 152846, 152848, 152933, 153333, 153503, 153698, 153825, 154466, 152071, 154125, 152263, 152412, 153090, 153436, 154448, 151600, 153724, 151697, 151697, 151907, 151908, 152135, 152148, 152156, 152168, 152321, 152396, 152400, 152401, 152402, 152564, 152592, 152654, 152730, 152731, 152752, 152822, 152825, 152836, 152889, 152890, 152891, 153000, 153042, 153043, 153173, 153174, 153175, 153212, 153241, 153371, 153382, 153386, 153415, 153445, 153807, 154026, 154353, 154461, 151705, 151763, 151770, 151779, 151782, 151803, 151820, 151828, 151842, 151847, 151848, 151861, 151864, 151866, 151875, 151881, 151882, 151886, 151931, 151933, 151962, 151965, 151969, 152023, 152036, 152051, 152064, 152079, 152080, 152091, 152154, 152174, 152176, 152246, 152248, 152262, 152301, 152307, 152308, 152352, 152356, 152373, 152425, 152427, 152433, 152446, 152448, 152454, 152522, 152536, 152549, 152717, 152760, 152787, 152881, 152898, 152939, 152965, 153031, 153194, 153430, 153434, 153595, 152277, 152285, 154356

Product

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Recalling firm

Elekta, Inc.

Quantity

1019 units

Distribution

worldwide

Recall date

December 13, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)