DKK Dai-Ichi Shomei Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2620-2024 | Class II | Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is inten | July 9, 2024 |
| Z-2621-2024 | Class II | Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is inten | July 9, 2024 |
| Z-2619-2024 | Class II | Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intend | July 9, 2024 |
| Z-2618-2024 | Class II | Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intend | July 9, 2024 |
| Z-0071-2024 | Class II | LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 se | August 23, 2023 |
| Z-0072-2024 | Class II | LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, | August 23, 2023 |