FDA recall Z-0072-2024

DKK Dai-Ichi Shomei Co., Ltd. · Class II · device

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

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

Key facts

Status
Ongoing
Initiation date
2023-08-23
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Itabashi, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2024