Class II — DKK Dai-Ichi Shomei Co., Ltd.
| Recalling firm | DKK DAI-ICHI SHOMEI CO, LTD |
|---|---|
| Registered facility | DKK DAI-ICHI SHOMEI CO, LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 | Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. |
| Quantity | 538 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. |
| Initiated | 2024-07-09 |
| Classified | 2024-08-14 |
| Recall number | Z-2621-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DKK Dai-Ichi Shomei Co., Ltd. (Z-2621-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94979/
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