Recall Z-0072-2024— DKK Dai-Ichi Shomei Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by DKK Dai-Ichi Shomei Co., Ltd., initiated 2023-08-23. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- DKK Dai-Ichi Shomei Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-23
- Firm location
- Itabashi, N/A, Japan
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.