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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93264

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 25, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Elekta, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Z-0442-2024
Recall number
Z-0442-2024
Initiated
October 25, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Elekta, Inc.
Quantity
315 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

worldwide

device · product 2 of 6

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

Z-0443-2024
Recall number
Z-0443-2024
Initiated
October 25, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Elekta, Inc.
Quantity
1019 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

worldwide

device · product 3 of 6

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

Z-0444-2024
Recall number
Z-0444-2024
Initiated
October 25, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Elekta, Inc.
Quantity
264 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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,

Distribution pattern

worldwide

device · product 4 of 6

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Z-0445-2024
Recall number
Z-0445-2024
Initiated
October 25, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Elekta, Inc.
Quantity
451 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

worldwide

device · product 5 of 6

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Z-0446-2024
Recall number
Z-0446-2024
Initiated
October 25, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Elekta, Inc.
Quantity
291 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

worldwide

device · product 6 of 6

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Z-0447-2024
Recall number
Z-0447-2024
Initiated
October 25, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Elekta, Inc.
Quantity
47 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

worldwide