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DKK Dai-Ichi Shomei Recalls
6 recalls on record · October 11, 2023 to August 21, 2024 · Medical Devices
Recalls by year
23
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 21, 2024Medical DevicesFDA
DKK Dai-Ichi Shomei Co., Ltd. recalls Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate th
Hazard: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
August 21, 2024Medical DevicesFDA
DKK Dai-Ichi Shomei Co., Ltd. recalls Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate th
Hazard: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
August 21, 2024Medical DevicesFDA
DKK Dai-Ichi Shomei Co., Ltd. recalls Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the
Hazard: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
August 21, 2024Medical DevicesFDA
DKK Dai-Ichi Shomei Co., Ltd. recalls Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the
Hazard: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
October 11, 2023Medical DevicesFDA
DKK Dai-Ichi Shomei Co., Ltd. recalls LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Au
Hazard: 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.
October 11, 2023Medical DevicesFDA
DKK Dai-Ichi Shomei Co., Ltd. recalls LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 serie
Hazard: 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.