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DKK Dai-Ichi Shomei Co., Ltd. FDA Recalls

6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate theClass IIJul 9, 2024The weld on the light head frame can crack which could lead	The weld on the light head frame can crack which could lead to problems such as the light head frame sagging,	Class IIDevices	Jul 9, 2024
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate thClass IIJul 9, 2024The weld on the light head frame can crack which could lead	The weld on the light head frame can crack which could lead to problems such as the light head frame sagging,	Class IIDevices	Jul 9, 2024
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate theClass IIJul 9, 2024The weld on the light head frame can crack which could lead	The weld on the light head frame can crack which could lead to problems such as the light head frame sagging,	Class IIDevices	Jul 9, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate thClass IIJul 9, 2024The weld on the light head frame can crack which could lead	The weld on the light head frame can crack which could lead to problems such as the light head frame sagging,	Class IIDevices	Jul 9, 2024
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 serieClass IIAug 23, 2023The stopper block on the LFS bracket could be broken or miss	The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen a	Class IIDevices	Aug 23, 2023
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, AuClass IIAug 23, 2023The stopper block on the LFS bracket could be broken or miss	The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen a	Class IIDevices	Aug 23, 2023

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