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

Recall number

Z-0444-2024

Recalling firm

Elekta, Inc.

Product

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

Status

Open, Classified

Initiated

2023-10-25

Posted

2023-12-01

Terminated

not on file

Reason

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.

Root cause

Under Investigation by firm

Action

Elekta released Field Safety Notice to its consignees on the 10/25/2023 via email. The notice explained the issue, potential risk, and provides information for the safe use of the instrument until Elekta Field Service Representatives can perform the correction.

Quantity

264 units

Distribution

worldwide

Lot, serial or model codes

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.

510(k) numbers

["K210500"]

PMA numbers

not on file

Product code

IYE

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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