| Class 2 Device Recall Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, a | |
Date Initiated by Firm | August 23, 2023 |
Date Posted | October 06, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0072-2024 |
Recall Event ID |
92999 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
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 |
Code Information |
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 |
Recalling Firm/ Manufacturer |
DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan
|
For Additional Information Contact | +8133969-9221 |
Manufacturer 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. |
FDA Determined Cause 2 | Device Design |
Action | An URGENT RECALL notification letter dated 8/23/23 was sent to the customer.
Actions to be Taken by the Manufacturer
We will provide an additional metal cover for the LFS bracket so that even if the shaft shears off, it will not pop out from the cover as well as instructions to properly install the cover. Also, the additional metal cover provides additional support to the LFS bracket and prevents the stopper block from broken or missing even if the excessive force is added to the bracket.
The physical correction will be announced later.
Other Information
Contact information for questions:
TEL: +81-3-3969-9221
FAX: +81-3-3969-9269
Email: info@hospilite.co.jp
Monday through Friday, 8:00 AM to 5:00 PM, Japan Standard Time. |
Quantity in Commerce | 1211 units |
Distribution | US States: MI |
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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