Device recall
Z-1091-2014: The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load…
FDA device recall · Class II · Instrumentarium Dental, PaloDEx Group Oy
Key facts
| Recall number (Z-number) | Z-1091-2014 |
|---|---|
| Recall event | 67342 |
| Product | The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data… |
| Product code | EHD |
| Recalling firm | Instrumentarium Dental, PaloDEx Group Oy |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2015 |
| 510(k) numbers | K022630 |
| FEI number | 3005383085 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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