medical Class II Updated 2023-10-11

DKK Dai-Ichi Shomei Co., Ltd. recalls LFS Flat screen support arm systems without surgical lamp fo

Recalled Product

LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers


Hazard / Issue

The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off.

Issued by

FDA

Affected States: MI
Lot/Code Info: Serial Numbers: RA000006, RA000007, RA000008, RA000009, RA000010, RA000244, RA000245, RA000246, RA000247, RA000248, RA000359, RA000360, RA000361, RA000362, RA000363, RA000364, RA000365, RA000366, RA000367, RA000368, RA000391, RA000393, RA000408, RA000410, RA000412, RA000414, RA000416, RA000418, RA000374, RA000459, RA000648, RA000712, RA000714, RA000716, RA000718, RA000720, RA000722, RA000724, RA000726, RA000751, RA000752, RA000753, RA000754, RA000755, RA000756, RA000757, RA000905, RA000907, RA000909, RA000911, RA000916, RA000918, RA000920, RA000922, RA000924, RA000926, RA001136, RA001138, RA001144, RA001145, RA001146, RA001147, RA001148, RA001197, RA001198, RA001199, RA001200, RA001201, RA001202, RA001203, RA001204, RA001205, RA001206, RA001189, RA001190, RA001244, RA001246, RA001252, RA001253, RA001254, RA001255, RA001256, RA001257, RA001287, RA001288, RA001289, RA001290, RA001291, RA001292, RA001299, RA001300, RA001345, RA001347, RA001374, RA001376, RA001377, RA001378, RA001379, RA001380, RA001381, RA001382, RA001383, RA001384, RA001385, RA001386, RA001434, RA001435, RA001439, RA001469, RA001470, RA001471, RA001472, RA001473, RA001474, RA001475, RA001476, RA001479, RA001480, RA001503, RA001529, RA001553, RA001555, RA001572, RA001573, RA001574, RA001575, RA001585, RA001576, RA001588, RA001664, RA001665, RA001666, RA001668, RA001669, RA001670, RA001710, RA001711, RA001712, RA001713, RA001714, RA001729, RA001732, RA001708, RA001709, BM003066, BM003067, BM003068, BM003069, BM003136, BM003137, BM003138, BM003262, BM003263, BM003264, BM003265, BM003266, BM003267, BM003268, BM003269, BM003270, BM003271, BM003272, BM003295, BM003296, BM003297, BM003298, BM003299, BM003907, BM003908, BM003909, BM003910, BM003911, BM003912, BM003913, BM003914, BM003915, BM003916, BM003917, BM003423 - BM003426, BM003497 - BM003506, BM003605 - BM003606, BM003607 - BM003613, BM003866 - BM003867, BM004072 - BM004072, BM004125 - BM004130, BM004188 - BM004195, BM004392 - BM004401, BM004721 - BM004724, BM004705 - BM004720, BM004725 - BM004725, BM004981 - BM004990, BM005290 - BM005299, BM005428 - BM005432, BM005433 - BM005434, BM005640 - BM005645, BM005805 - BM005810, BM005948 - BM005949, BM006021 - BM006026, BM006113 - BM006118, BM006268 - BM006270, BM006453 - BM006464, BM006465 - BM006468, BM006575 - BM006580, BM006637 - BM006643, BM006644 - BM006646, BM006717 - BM006722, BM006790 - BM006791, BM006794 - BM006805, BM006792 - BM006793, BM007021 - BM007030, BM007031 - BM007036, BM007144 - BM007147, BM007239 - BM007244, BM007245 - BM007248, BM007359 - BM007364, BM007365 - BM007370, BM007502 - BM007507, BM007624 - BM007627, BM007800 - BM007807, BM007808 - BM007811, BM008045 - BM008054, BM008151 - BM008155, BM008206 - BM008215, BM008406 - BM008415, BM008577 - BM008586, BM008679 - BM008688, BM008739 - 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BM014262, BM014468 - BM014477, BM014629 - BM014633, BM014931 - BM014932, BM015038 - BM015042, BM015115 - BM015124, BM015175 - BM015184, BM015278 - BM015285, BM015286 - BM015289, BM015523 - BM015527, BM015653 - BM015657, BM015658 - BM015661, BM015857 - BM015861, BM016047 - BM016051, BM016054 - BM016055, BM016056 - BM016060, BM016401 - BM016402, BM016530 - BM016543, BM017090 - BM017091, BM017196 - BM017197, BM017303 - BM017306, BM017307 - BM017310, BM017386 - BM017389, BM017402 - BM017405, BM017442 - BM017445, BM017814 - BM017815, BM017816 - BM017817, BM017902 - BM017904, BM017963 - BM017966, BM017967 - BM017969, BM018102 - BM018103, BM018104 - BM018106, BM018185 - BM018187, BM018188 - BM018189, BM018243 - BM018245, BM018246 - BM018247, BM018248 - BM018249, BM018282 - BM018283, BM018370 - BM018374, BM018375 - BM018375, BM018447 - BM018450, BM018451 - BM018452, BM018474 - BM018476, BM018477 - BM018478, BM018479 - BM018480, BM018662 - BM018667, BM018668 - BM018669, BM018677 - BM018680, BM018681 - BM018682, BM018962 - BM018967, BM019058 - BM019061, BM019253 - BM019256, BM019348 - BM019352, BM019561 - BM019563, BM019674 - BM019676, BM019677 - BM019678, BM020498 - BM020499, BM020601 - BM020604, BM020704 - BM020705, BM020801 - BM020803, BM020899 - BM020900, BM020901 - BM020902, BM021002 - BM021003, BM021091 - BM021092, BM021183 - BM021184, BM021339 - BM021341, BM021730 - BM021733, BM021734 - BM021735, BM021823 - BM021824, BM021825 - BM021826, BM022127 - BM022128, BM022329 - BM022332, BM022416 - BM022417, BM022457 - BM022458, BM022533 - BM022534, BM022535 - BM022536, BM022537 - BM022538, BM022606 - BM022607, BM022608 - BM022609, BM022676 - BM022677, BM022678 - BM022681, BM022761 - BM022762, BM022830 - BM022833, BM022907 - BM022908, BM022909 - BM022911, BM022995 - BM022996, BM023075 - BM023076, BM023155 - BM023156, BM023157 - BM023158, BM023249 - BM023250, BM023331 - BM023332, BM023333 - BM023334, BM023398 - BM023400, BM023583 - BM023584, BM024411 - BM024412, BM024612 - BM024613, BM024643 - BM024645, BM025092 - BM025099, BM025349 - BM025351, BM025417 - BM025419, BM025420 - BM025421, BM025422, BM025940, BM025941 - BM025946, BM025947 - BM025948, BM026027 - BM026030, BM026281, BM026405, BM026879 - BM026884, BM027023 - BM027032, BM027081 - BM027085, BM027133 - BM027134, BM027135 - BM027136, BM027210, BM027211, BM027303 - BM027304, BM027477 - BM027478, BM027609 - BM027611, BM027737 - BM027738, BM027838, BM028212 - BM028214, BM028215 - BM028216, BM029320 - BM029325, BM029668 - BM029673
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