Device recall
Z-1265-2009: Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product…
FDA device recall · Class II · Imaging Sciences International, LLC
Key facts
| Recall number (Z-number) | Z-1265-2009 |
|---|---|
| Recall event | 51424 |
| Product | Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation. |
| Product code | MUH |
| Recalling firm | Imaging Sciences International, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2009 |
| 510(k) numbers | K061284 |
| FEI number | 3021551875 |
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