Device recall
Z-2564-2014: Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per…
FDA device recall · Class II · Hitachi Medical Systems America Inc
Key facts
| Recall number (Z-number) | Z-2564-2014 |
|---|---|
| Recall event | 68758 |
| Product | Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. |
| Product code | LNH |
| Recalling firm | Hitachi Medical Systems America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2015 |
| 510(k) numbers | K113145 |
| 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