# FDA recall Z-2618-2024

> **DKK Dai-Ichi Shomei Co., Ltd.** · Class II · device recall initiated 2024-07-09.

## 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

- **Recall number:** Z-2618-2024
- **Recalling firm:** DKK Dai-Ichi Shomei Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-09
- **Report date:** 2024-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Itabashi, Japan

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2618-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2618-2024. Source: US FDA. Licensed CC0.

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