FDA recall Z-2618-2024

DKK Dai-Ichi Shomei Co., Ltd. · Class II · device

Product

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-07-09
Report date
2024-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Itabashi, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2618-2024