Device recall
Z-0296-2008: Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103…
FDA device recall · Class II · Xoran Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0296-2008 |
|---|---|
| Recall event | 45529 |
| Product | Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging. |
| Product code | JAK |
| Recalling firm | Xoran Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2008 |
| 510(k) numbers | K032243 |
| FEI number | 3004198450 |
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