Device recall
Z-2839-2018: Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated…
FDA device recall · Class II · Hitachi Medical Systems America Inc
Key facts
| Recall number (Z-number) | Z-2839-2018 |
|---|---|
| Recall event | 80671 |
| Product | Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the… |
| Product code | JAK |
| Recalling firm | Hitachi Medical Systems America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2020 |
| 510(k) numbers | K150595 |
| FEI number | 1528028 |
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