Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-0072-2024

U.S. FDA — Device Enforcement · Japan · 2023-08-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0072-2024
Date of alert
2023-08-23
Country / jurisdiction
Japan
Risk level
Class II
Risk type
recall
Brand
DKK Dai-Ichi Shomei Co., Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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