LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Au

FDA device recall Z-0072-2024 · posted 2023-10-06 · Open, Classified

Recall details

Recalling firm

DKK Dai-Ichi Shomei Co., Ltd.

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.

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.

Root cause

Device Design

Status

Open, Classified

Product code

FSY

Quantity affected

1211 units

Distribution

US States: MI

Date initiated

2023-08-23

Date posted

2023-10-06

Location

Itabashi, Sakashita, Japan