DKK Dai-Ichi Shomei Co., Ltd.: Device Recall

Recall Details

Recall Number

Z-2618-2024

Classification

Class II

Product Type

Device

Recalling Firm

DKK Dai-Ichi Shomei Co., Ltd.

Status

Ongoing

Date Initiated

07/09/2024

Location

Itabashi, Japan

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

555 units

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.

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.

Distribution Pattern

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

Other Recalls by DKK Dai-Ichi Shomei Co., Ltd.

• Class II: Risk 07/09/2024
  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: Risk 07/09/2024
  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: Risk 07/09/2024
  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.

View all recalls by DKK Dai-Ichi Shomei Co., Ltd. →