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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Elekta, Inc.: Elekta Linear Accelerators Recalled for Detector Arm Safety Issue

Agency Publication Date: December 1, 2023
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Summary

Elekta, Inc. is recalling 2,387 units of various linear accelerator models, including the Precise Digital Accelerator, Elekta Synergy, Synergy Platform, Versa HD, Elekta Infinity, and Elekta Axesse. The recall was initiated because a microswitch within the device's middle arm may be incorrectly set up, which can cause the detector arms (iViewGT or XVI) to extend in an uncontrolled manner. This issue occurs when the arm is in transition, though there is no risk once the arm is fully deployed. Consumers should contact the manufacturer to ensure their system is inspected and corrected.

Risk

If the detector arm extends unexpectedly or without control during a medical procedure, it could potentially strike a patient or medical staff, leading to physical injury. While no specific injuries were reported in this notice, the mechanical failure poses a risk of impact during device operation.

What You Should Do

  1. Identify if your medical facility uses any of the following Elekta Linear Accelerators: Precise Digital Accelerator, Elekta Synergy, Elekta Synergy Platform, Versa HD, Elekta Infinity, or Elekta Axesse.
  2. Check your device's serial number against the extensive list provided in the recall notice. Affected serial numbers include, but are not limited to, 152320, 105566, 154549, 152110, 153396, 153451, and 152140.
  3. Verify the Unique Device Identifier (UDI/DI) numbers on your equipment: 05060191071505, 05060191071550, 05060191071536, 05060191071567, 05060191071529, 05060191071574, 05060191071512, or 05060191071543.
  4. Contact your healthcare provider or Elekta, Inc. immediately at their distributor address (400 Perimeter Center Ter NE Ste 50, Atlanta, Georgia) for technical support and to schedule a mandatory inspection or correction of the middle arm microswitch.
  5. Continue to use the device only if the detector arm is fully deployed, as the manufacturer has stated there is no risk of uncontrolled extension once the arm is in its final position.
  6. For additional information or questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer-led device inspection and correction of the middle arm microswitch setup.

How to: Contact your healthcare provider or the manufacturer (Elekta, Inc.) for further instructions and to facilitate the necessary device corrections.

Affected Products

Product: ELEKTA LIMITED Precise Digital Accelerator (REF MRT 6001, MRT 6011)
Model / REF:
MRT 6001
MRT 6011
Lot Numbers:
Serial Numbers: 152320, 105566, 152018, 152077, 152078, 152142, 152196, 152326, 152327, 152328, 152434, 152493, 152552, 152640, 152680, 152922, 152940, 152943, 153244, 153366, 153528, 153549, 153609, 153806, 154332, 154365, 151606, 151642, 151648, 151650, 151721, 151726, 151742, 151776, 151777, 151806, 151817, 151856, 151877, 151926, 151929, 151944, 151947, 152096, 152139, 152149, 152150, 152153, 152225, 152265, 152269, 152274, 152279, 152289, 152292, 152317, 152332, 152333, 152335, 152348, 152383, 152407, 152410, 152413, 152444, 152466, 152470, 152471, 152476, 152485, 152488, 152489, 152496, 152508, 152517, 152527, 152534, 152555, 152566, 152587, 152590, 152608, 152621, 152641, 152661, 152670, 152684, 152686, 152688, 152690, 152699, 152722, 152748, 152751, 152761, 152766, 152771, 152781, 152786, 152788, 152789, 152790, 152808, 152821, 152832, 152845, 152859, 152863, 152865, 152866, 152870, 152909, 152918, 152934, 152961, 153009, 153013, 153020, 153040, 153041, 153064, 153067, 153069, 153070, 153129, 153134, 153145, 153150, 153154, 153155, 153157, 153159, 153165, 153167, 153213, 153214, 153216, 153231, 153242, 153254, 153260, 153262, 153274, 153304, 153306, 153311, 153318, 153322, 153328, 153329, 153338, 153351, 153353, 153368, 153374, 153443, 153457, 153460, 153462, 153488, 153490, 153494, 153538, 153545, 153547, 153561, 153569, 153571, 153576, 153581, 153583, 153599, 153603, 153618, 153622, 153627, 153650, 153654, 153680, 153682, 153686, 153695, 153709, 153721, 153730, 153731, 153732, 153771, 153773, 153779, 153783, 153790, 153795, 153805, 153881, 153904, 153909, 153910, 153918, 153921, 153927, 153931, 153934, 153945, 153956, 153967, 153971, 153993, 153994, 154033, 154035, 154047, 154061, 154062, 154074, 154081, 154092, 154094, 154096, 154114, 154118, 154246, 154249, 154313, 154329, 154341, 154376, 154459, 154465, 154474, 154517, 151732, 152675, 151012, 105940, 151204, 151409, 151559, 151878, 152169, 152423, 152424, 151131, 151283, 152706, 151475, 152113, 152644, 153080, 153170, 153183, 153184, 153289, 154480, 153226, 153540, 153962, 154154, 151271, 152055, 152065, 152121, 152134, 152218, 152219, 151464, 105306, 151761, 152029, 105715, 152144, 153403, 151807, 151741, 152674, 152677, 153690, 151715, 151716, 151520, 153544, 151901, 152037, 152187, 152571, 152799, 154439, 154440, 153633, 152013, 151126, 105640, 151534, 152967, 152968, 153461, 153521, 153864, 154034, 105490, 152473, 151095, 152556, 151374, 151456, 151457, 151980, 152198, 152278, 153193, 153206, 153582, 154186, 154278, 151549
Product: ELEKTA LIMITED Elekta Synergy (REF MRT 8501, MRT 8511)
Model / REF:
MRT 8501
MRT 8511
UPC Codes:
05060191071505
05060191071550
Lot Numbers:
Serial Numbers (UDI 05060191071505): 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
Serial Numbers (UDI 05060191071550): 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
Product: ELEKTA LIMITED Elekta Synergy Platform (REF MRT 8501, MRT 8511)
Model / REF:
MRT 8501
MRT 8511
UPC Codes:
05060191071536
05060191071567
Lot Numbers:
Serial Numbers (UDI 05060191071536): 152110, 153550, 153363, 152650, 151851, 153300, 152721, 152816, 152539, 153879, 154099, 154121, 154230, 154581, 151909, 152186, 152314, 152542, 152728, 152643, 151984, 153334, 152057, 152086, 152107, 152129, 152907, 153327, 153820, 153844, 153084, 151712, 151713, 153522, 151873, 152501, 153675, 151834, 151923, 151924, 151925, 152076, 154100, 151725, 151804, 151825, 151826, 152337, 152338, 152339, 152662, 152936, 153629, 153632, 153676, 153678, 152397, 153636
Serial Numbers (UDI 05060191071567): 152718, 153868, 153870, 153877, 153948, 154180, 152778, 151562, 151563, 151991, 151992, 151993, 152213, 152450, 152456, 152531, 152642, 152663, 152782, 152791, 152829, 152862, 152962, 153125, 153270, 153343, 153759, 153789, 153886, 154145, 154147, 154247, 154330, 154499, 153925, 154201, 152171, 152280, 151750, 152221, 152255, 152509, 152558, 152612, 152831, 153066, 153135, 153229, 153246, 153704, 153772, 154191, 154428, 154510, 152146, 152355, 151994, 152001, 153098, 152436, 152935, 153414, 153811, 154270, 154471, 154472, 154136, 151858, 152209, 152384, 152497, 152498, 153111, 153156, 153362, 153446, 153718, 154058, 152486, 153234, 153747, 151772, 151840, 151949, 152170, 152312, 152368, 152480, 152672, 152687, 152739, 152753, 152899, 152904, 152913, 152919, 152952, 152977, 153060, 153168, 153284, 153297, 153325, 153349, 153551, 153553, 153605, 153660, 153770, 153813, 153888, 153920, 153955, 154006, 154228, 154238, 154240, 154446, 109008, 151731, 152702, 152869, 154029, 154102, 151453, 152840, 152841, 153388, 153389, 153440, 153683, 152873, 152958, 153423, 151872, 153266, 153505, 153714, 151880, 152341, 152342, 153326, 153205, 153977, 153178, 152319, 154010, 152306, 153737, 153760, 152191, 152638, 153059, 154235, 154309, 151964, 153119, 154041, 152367, 153972, 153981, 153983, 153992, 152184, 152708, 152231, 153809, 151863, 152270, 152794, 152982, 153516, 153885, 154253, 154295, 154318, 154357, 151665, 152058, 152059, 152404, 152723, 152598, 154463, 152120, 152143, 153089, 153092, 153579, 153850, 154122, 152479, 152858, 152878, 151849, 152155, 152205, 152483, 152377, 152378, 152380, 152381, 153137, 154037, 154563, 153688
Product: ELEKTA LIMITED Versa HD (REF XRT 2121, 2131)
Model / REF:
XRT 2121
2131
UPC Codes:
05060191071529
05060191071574
Lot Numbers:
Serial Numbers (UDI 05060191071529): 153396, 153671, 109003, 153383, 153384, 153055, 153980, 154001, 154002, 154003, 154004, 154272, 153104, 153188, 153243, 153745, 153836, 153872, 153876, 154123, 154148, 154199, 154250, 154260, 154267, 154269, 154449, 154498, 154550, 152951, 153140, 153525, 153526, 153532, 154218, 153621, 153951, 153949, 154028, 154548, 154239, 154262, 153413, 153829, 154163, 154101, 152777, 153037, 153142, 153144, 153177, 153186, 153187, 153189, 153277, 153364, 153399, 153425, 153426, 153471, 153510, 153537, 153578, 153625, 153661, 153752, 153762, 153782, 153797, 153808, 153816, 153847, 153858, 153950, 153986, 153997, 154046, 154070, 154084, 154085, 154127, 154178, 154202, 154217, 154280, 154372, 154374, 154381
Serial Numbers (UDI 05060191071574): 153722, 109005, 109007, 153003, 153008, 153314, 153337, 153427, 153428, 153482, 153649, 153900, 154023, 154024, 154050, 154087, 154299, 154300, 153248, 153699, 154043, 154395, 154435, 154179, 154131, 153658, 153830, 154221, 154473, 153976, 153128, 153608, 154505, 154531, 154325, 153406, 153601, 153607, 153667, 153720, 153723, 153751, 153839, 153862, 153940, 153985, 154055, 154076, 154140, 154149, 154283, 154293, 154296, 154375, 154421, 154398, 152843, 152912, 153778, 153893, 153894, 154327, 154328, 154408, 153379, 153381, 152917, 153113, 153452, 153453, 154077, 154198, 154258, 154450, 153835, 153023, 153025, 153095, 153106, 153180, 153249, 153279, 153281, 153320, 153356, 153359, 153380, 153385, 153470, 153619, 153656, 153702, 153706, 153711, 153765, 153791, 153801, 154027, 154057, 154128, 154216, 154301, 154382, 154383, 154386, 154390, 154470, 154479, 154497, 154502, 154562, 153628, 154133, 154167, 154226, 154369, 153715, 153151, 153232, 153315, 153432, 153455, 153524, 153539, 153846, 153857, 153929, 154016, 154021, 154031, 154032, 154142, 154187, 154214, 154225, 154233, 154257, 154285, 154320, 154400, 154402, 154412, 154444, 154462, 154464, 154509, 154541, 154284, 153239, 154279, 154500, 153739, 153412, 153433, 153485, 153860, 153936, 153978, 153996, 154012, 154013, 154174, 154236, 154416, 153594, 153689, 153776, 153902, 153905, 153965, 153998, 154040, 154158, 154172, 154197, 154200, 154222, 154254, 154436, 154481, 154291, 154298, 154410, 153287, 153459, 153612, 153647, 153657, 154022, 154430, 154348, 153563, 153564, 153437, 153110, 153222, 153454, 153766, 153775, 154150, 154151, 154152, 154334, 154335, 154336, 154337, 154338, 154511, 109004, 153130, 153163, 154039, 153245, 153589, 153637, 153837, 153932, 154038, 154442, 153185, 154251, 154252, 154268, 154271, 153611, 153662, 152960, 153913, 153916, 153959, 153968, 153513, 153316, 153679, 153417, 154379, 154438, 153181, 153467, 153562, 154124, 154333, 154373, 154503, 154513, 154544, 152995, 154219, 154529, 153517, 153642, 153713, 153838, 153975, 154212, 154276, 153438, 154406, 153250, 153479, 153861, 154112, 154274, 154275, 154445, 154456, 154490, 152944, 153096, 153097, 153171, 153225, 153307, 153369, 153418, 153439, 153818, 153833, 153851, 154059, 154063, 154176, 154207, 154227, 154331, 154346, 154347, 154350, 154351, 154352, 154354, 154358, 154360, 154361, 154362, 154458, 154476, 154496, 152948, 152954, 153044, 153278, 153295, 153312, 153340, 153373, 153376, 153435, 153447, 153456, 153466, 153468, 153486, 153487, 153492, 153585, 153614, 153624, 153638, 153664, 153687, 153705, 153716, 153796, 153832, 153843, 153890, 153892, 153897, 153903, 153908, 153941, 153990, 153991, 154017, 154020, 154066, 154083, 154105, 154111, 154137, 154170, 154171, 154173, 154184, 154185, 154190, 154193, 154195, 154243, 154245, 154322, 154323, 154339, 154340, 154388, 154413, 154426, 154427, 154431, 154518, 154559, 154349
Product: ELEKTA LIMITED Elekta Infinity (REF XRT 0511, XRT 0521, XRT 0531, XRT 0541)
Model / REF:
XRT 0511
XRT 0521
XRT 0531
XRT 0541
UPC Codes:
05060191071512
05060191071543
Lot Numbers:
Serial Numbers (UDI 05060191071512): 153451, 154067, 154072, 153600, 153693, 152596, 152649, 152834, 152956, 152957, 153005, 153054, 153377, 153593, 153602, 153617, 153852, 154048, 154049, 154060, 152971, 152597, 151995, 153685, 154560, 153748, 153979, 153989, 152902, 153670, 152937, 153198, 151839, 151942, 151958, 151959, 151961, 152019, 152103, 152115, 152158, 152207, 152210, 152211, 152223, 152257, 152303, 152364, 152371, 152504, 152520, 152585, 152593, 152604, 152652, 152659, 152715, 152732, 152801, 152802, 152817, 152818, 152828, 152833, 152916, 152927, 152946, 152963, 152970, 152993, 153035, 153046, 153071, 153138, 153141, 153143, 153164, 153200, 153230, 153375, 153450, 153474, 153529, 153534, 153542, 153558, 153727, 153746, 153753, 153761, 153794, 153803, 153824, 153826, 153840, 153871, 153915, 153939, 154051, 154093, 154132, 154135, 154169, 154175, 154204, 154206, 154224, 154242, 154244, 154264, 154312, 154378, 154380, 154422, 154429, 154453, 154536, 154558
Serial Numbers (UDI 05060191071543): 153741, 154363, 152506, 152768, 152969, 153004, 153047, 153048, 153120, 153121, 152478, 152772, 153303, 153402, 153626, 152668, 152669, 152692, 152853, 152979, 152984, 153015, 153017, 153053, 153308, 153802, 154065, 153946, 153960, 154082, 154130, 154144, 154189, 154229, 154289, 154290, 154302, 154311, 154414, 154423, 154475, 153472, 152888, 153298, 154277, 154297, 154310, 154355, 154434, 151044, 152554, 153076, 153237, 153324, 153586, 153961, 154211, 154403, 154231, 153441, 153236, 153511, 153646, 153652, 153655, 153674, 153677, 153845, 153869, 153982, 154134, 154159, 154208, 154209, 154213, 152996, 153010, 153052, 153285, 153288, 153294, 153792, 153799, 154115, 154467, 153350, 153866, 152370, 153878, 154366, 154582, 153933, 153001, 154181, 154205, 153531, 153631, 153692, 153743, 153987, 154045, 154468, 152709, 153615, 153103, 153332, 153907, 153091, 152031, 152163, 152175, 152192, 152200, 152222, 152388, 152392, 152432, 152469, 152481, 152491, 152502, 152556, 152599, 152601, 152618, 152673, 152784, 152792, 152798, 152955, 152959, 153019, 153021, 153032, 153036, 153050, 153061, 153068, 153114, 153136, 153253, 153282, 153319, 153321, 153342, 153354, 153429, 153442, 153448, 153464, 153491, 153493, 153535, 153536, 153548, 153597, 153598, 153681, 153719, 153738, 153749, 153798, 154069, 154117, 154182, 154319, 154387, 154485, 154504, 154512, 154535, 154565, 154265
Product: ELEKTA AXESSE (REF XRT 2181, XRT 27891)
Model / REF:
XRT 2181
XRT 27891
Lot Numbers:
Serial Numbers: 152140, 152617, 152691, 152004, 152683, 152994, 153935, 152620, 152809, 152854, 152867, 152885, 152964, 152974, 153192, 153217, 153527, 152499, 153668, 152519, 153118, 153102, 153204, 153166, 152017, 152112, 152325, 152749, 1527449, 152754, 152755, 152756, 152860, 153006, 151874, 152538, 152839, 152921, 153149, 153267, 152736, 151793, 151802, 151812, 151960, 152600, 152678, 152838

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93264
Status: Active
Manufacturer: Elekta, Inc.
Sold By: Specialized medical device distributors; Elekta authorized direct sales
Manufactured In: United States
Units Affected: 6 products (315 units; 1019 units; 264 units; 451 units; 291 units; 47 units)
Distributed To: Nationwide

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

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