PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: August 21, 2024 Initiated: July 9, 2024 #Z-2618-2024

Product Description

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.

Details

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

Frequently Asked Questions

What product was recalled?
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.. Recalled by DKK Dai-Ichi Shomei Co., Ltd.. Units affected: 555 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 21, 2024. Severity: Moderate. Recall number: Z-2618-2024.