Device recall
Z-2037-2012: Hitachi Scenaria CT System Software Product Usage: The Scenaria system is…
FDA device recall · Class II · Hitachi Medical Systems America Inc
Key facts
| Recall number (Z-number) | Z-2037-2012 |
|---|---|
| Recall event | 62372 |
| Product | Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the… |
| Product code | JAK |
| Recalling firm | Hitachi Medical Systems America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2013 |
| 510(k) numbers | K101888 |
| 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