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Class 2 Device Recall Elekta Synergy, Elekta Harmony", Elekta Infinity ", Versa HD" |
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Date Initiated by Firm |
October 25, 2023 |
Date Posted |
December 01, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0444-2024 |
Recall Event ID |
93264 |
510(K)Number |
K210500
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Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product |
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear |
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. |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter NE Ste 50 Atlanta GA 30346-1227
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For Additional Information Contact |
770-670-2422
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Manufacturer 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.
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FDA Determined Cause 2 |
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 in Commerce |
264 units |
Distribution |
worldwide |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = Elekta Limited
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