FDAClass IIOctober 11, 2023

LFS Flat screen support arm systems without surgical recall

LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro…

Why was LFS Flat screen support arm systems without surgical recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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 - BM008748, BM009115 - BM009124, BM009393 - BM009402, BM009522 - BM009535, BM009542 - BM009542, BM009610 - BM009614, BM009615 - BM009624, BM009718 - BM009733, BM009734 - BM009738, BM009739 - BM009740, BM009741 - BM009744, BM009961 - BM009965, BM010144 - BM010148, BM010149 - BM010149, BM010541 - BM010545, BM010874 - BM010878, BM010939 - BM010939, BM011000 - BM011004, BM011172 - BM011176, BM011259 - BM011263, BM011447 - BM011451, BM011547 - BM011556, BM011740 - BM011754, BM011847 - BM011856, BM011927 - BM011936, BM012134 - BM012134, BM012047 - BM012056, BM012242 - BM012246, BM012247 - BM012251, BM012252 - BM012256, BM012352 - BM012356, BM012423 - BM012427, BM012430 - BM012439, BM012500 - BM012500, BM012636 - BM012645, BM012732 - BM012741, BM012862 - BM012871, BM013163 - BM013164, BM013159 - BM013162, BM013262 - BM013269, BM013355 - BM13359, BM013449 - BM13453, BM013632 - BM013632, BM013634 - BM013638, BM013804 - BM013808, BM013905 - BM013909, BM014076 - BM014077, BM014263 - BM014264, BM014253 - 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

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…
Recalling firm
DKK Dai-Ichi Shomei Co., Ltd.
Quantity
1211 units
Distribution
US States: MI
Recall date
October 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls