FDA-Device2024-08-21Class II
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
DKK Dai-Ichi Shomei Co., Ltd.
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.
Sold states
Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
Affected count
293 units
Manufactured in
1 Chome 32-26, Sakashita, Itabashi, Japan
Products
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2620-2024Don't want to check this manually?
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