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U.S. Department of Health and Human Services

Class 2 Device Recall Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, a

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  Class 2 Device Recall Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, a see related information
Date Initiated by Firm August 23, 2023
Date Posted October 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-0071-2024
Recall Event ID 92999
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product LFS Flat screen arm system with 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 Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC
Code Information Serial Numbers: 06087323 - 06087352, 06087353 - 06087354, 06081292 - 06081293, 06087448 - 06087449, 06087450 - 06087469, 06097595 - 06097596, 06107716 - 06107718, 06107719 - 06107728, 06107730, 06107731 - 06107732, 06111348 - 06111349, 06117855 - 06117856, 06117857 - 06117866, 06117868 - 06117868, 06111350 - 06111351, 06117949 - 06117949, 06117954 - 06117973, 06118031 - 06118032, 06128116 - 06128131, 06128172 - 06128176, 06128177 - 06128186, 06128187 - 06128188, 07010004, 07010002, 07010005 - 07010006, 07028436 - 07028441, 07030080 - 07030081, 07048491 - 07048495, 07058506 - 07058507, 07058508 - 07058512, 07068602 - 07068604, 07068605 - 07068607, 07068611 - 07068622, 07068609 - 07068610, 07068667 - 07068670, 07061479 - 07061484, 07078679 - 07078680, 07071485 - 07071488, 07071501, 07088741 - 07088742, 07081124, 07088766, 07098769 - 07098773, 07098767 - 07098768, 07098774 - 07098775, 07108885 - 07108889, 07108883 - 07108884, 07108876 - 07108882, 07108890 - 07108891, 07101533 - 07101534, 07129027 - 07129028, RA000182, RA000184, 08029174 - 08029183, 08029187 - 08029188, 08029189 - 08029190, 09111694, 10011776, 10011777, 10011778, 10011779, 10011780, 10011781, 10011782, 10051792, 10051794, 10051796, 10051798, 10051800, 10051802, 10051804, 100610044, 100610045, 100610046, 100610047, 100610048, 100610049, 100610050, 100610051, 100610052, 100610053, 101010180, 101010182, 101010184, 101010186, 101010188, 101010190, 101010192, 101210252, BM005435 - BM005435, BM006121 - BM006121, BM008121 - BM008127
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 256 units
Distribution US States: MI
Total Product Life Cycle TPLC Device Report
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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