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
This recall is currently active, issued October 6, 2023. It was issued by Dkk Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan.
- Recall Initiated
- August 23, 2023
- Posted
- October 6, 2023
- Recall Number
- Z-0071-2024
- Quantity
- 256 units
- Official Source
- View on FDA website ↗
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
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.