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
FDA Recall Z-0072-2024 · Posted 2023-10-06
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Recalling FirmDKK Dai-Ichi Shomei Co., Ltd.
Recall StatusOpen, Classified
Product CodeFSY
Date Initiated2023-08-23
Product Quantity1211 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.
Firm 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: [email protected]
Monday through Friday, 8:00 AM to 5:00 PM, Japan Standard Time.
Root Cause
Device Design
Distribution Pattern
US States: MI
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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