Device recall
Z-2047-2021: Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic…
FDA device recall · Class II · Canon Medical System, USA, INC.
Key facts
| Recall number (Z-number) | Z-2047-2021 |
|---|---|
| Recall event | 88014 |
| Product | Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging… |
| Product code | LNH |
| Recalling firm | Canon Medical System, USA, INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203553 |
| FEI number | 2020563 |
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