Use caution Medical device recall · FDA · Published October 25, 2023
Elekta Infinity Medical Radiation Therapy System Recall: Risk of Uncontrolled Detector Arm
Elekta recalls specific models of Infinity radiation therapy systems due to potential uncontrolled extension of detector arms if microswitch is incorrectly set up. Affected units include serial numbers starting with 152596 to 154565.
Use caution until it’s fixed
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
Contact the company
Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227
What happened, in plain English
Elekta is recalling certain Infinity radiation therapy systems that may have a microswitch issue causing detector arms to extend uncontrollably. This could pose a risk during medical procedures if the arms are not properly secured. Read more at govinfonow.com/recall/57001-elekta-infinity-medical-radiation-therapy-system-recall-risk-of-uncontrolled.
Source Summary by GovInfoNow · govinfonow.com/recall/57001-elekta-infinity-medical-radiation-therapy-system-recall-risk-of-uncontrolled · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0446-2024
Cite this page
“Elekta Infinity Medical Radiation Therapy System Recall: Risk of Uncontrolled Detector Arm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57001-elekta-infinity-medical-radiation-therapy-system-recall-risk-of-uncontrolled. Based on FDA recall #Z-0446-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0446-2024%22&limit=1).
Why it’s dangerous
If the microswitch in the middle arm is incorrectly set up, the detector arms could extend uncontrollably during use. However, the hazard only occurs when the arms are fully deployed and there is no risk of extension when the detector arm is fully deployed.
Who’s affected
Medical facilities using Elekta Infinity radiation therapy systems with specific serial numbers listed in the recall notice are most at risk. Patients undergoing treatment with these systems may need to be monitored for potential complications.
How to tell if you have this one
Check if your Elekta Infinity system has serial numbers listed in the recall notice (e.g., 152596 to 154565). The product is a medical radiation therapy system used for cancer treatment.
- Brand
Elekta- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
worldwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0442-2024 | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear; UDI/DI none, 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 | 315 units |
| Z-0443-2024 | ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear; 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 | 1019 units |
| Z-0444-2024 | ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear; UDI/DI 05060191071536, Serial Numbers: 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; UDI/DI 05060191071567, Serial Numbers: 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, | 264 units |
| Z-0445-2024 | ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear; UDI/DI 05060191071529, Serial Numbers: 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; UDI/DI 05060191071574, Serial Numbers: 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 | 451 units |
| Z-0446-2024 | ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear; UDI/DI 05060191071512, Serial Numbers: 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; UDI/DI 05060191071543, Serial Numbers: 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 | 291 units |
| Z-0447-2024 | ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear; UDI/DI N/A, 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, 152754, 152755, 152756, 152860, 153006, 151874, 152538, 152839, 152921, 153149, 153267, 152736, 151793, 151802, 151812, 151960, 152600, 152678, 152838 | 47 units |
What to do — step by step
Check System Serial Number
Verify if your Elekta Infinity system has a serial number listed in the recall notice (e.g., 152596 to 154565).
How this recall unfolded
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this system?
Check your system's serial number against the list provided in the recall notice. If it matches, contact Elekta for further instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0446-2024 (October 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0446-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.