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 th…

Recall date

July 9, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2619-2024

FDA classification

Class II

Brand / firm

DKK Dai-Ichi Shomei Co., Ltd.

Sold / distributed

Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.