Device recall
Z-0816-2007: Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional…
FDA device recall · Class II · Instrumentarium Dental, Inc.
Key facts
| Recall number (Z-number) | Z-0816-2007 |
|---|---|
| Recall event | 37838 |
| Product | Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland. |
| Product code | EDH |
| Recalling firm | Instrumentarium Dental, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2008 |
| 510(k) numbers | K974877 |
| FEI number | 3005383085 |
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