Device recall
Z-1548-2009: Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex…
FDA device recall · Class II · Gendex Dental Systems
Key facts
| Recall number (Z-number) | Z-1548-2009 |
|---|---|
| Recall event | 51485 |
| Product | Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. |
| Product code | MUH |
| Recalling firm | Gendex Dental Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 7, 2011 |
| 510(k) numbers | K060178 |
| FEI number | 3004115000 |
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