Device recall
Z-2618-2024: Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The…
FDA device recall · Class II · DKK Dai-Ichi Shomei Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2618-2024 |
|---|---|
| Recall event | 94979 |
| 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. |
| Product code | FSY |
| Recalling firm | DKK Dai-Ichi Shomei Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K071698 |
| FEI number | 3006437518 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database