Device recall
Z-1534-2010: Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The…
FDA device recall · Class II · Hitachi Medical Systems America Inc
Key facts
| Recall number (Z-number) | Z-1534-2010 |
|---|---|
| Recall event | 54264 |
| Product | Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial… |
| Product code | IWE |
| Recalling firm | Hitachi Medical Systems America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2012 |
| 510(k) numbers | K072279 |
| FEI number | 1528028 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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