LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Au
Summary
The FDA issued a Class II for LFS Flat screen support arm systems without surgical lamp for models Aurora seri by DKK Dai-Ichi Shomei Co., Ltd.. Reason: 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 ca.
Details
Source
Device Recall
External ID
Z-0072-2024
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
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
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 - 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
Quantity Affected: 1211 units
Reason for Recall
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.
Distribution
US States: MI
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-23
Company
Itabashi, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DKK Dai-Ichi Shomei Co., Ltd. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DKK Dai-Ichi Shomei Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DKK Dai-Ichi Shomei Co., Ltd. have FDA actions?
DKK Dai-Ichi Shomei Co., Ltd. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0072-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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