Device recall
Z-0543-2010: i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences…
FDA device recall · Class II · Imaging Sciences International, LLC
Key facts
| Recall number (Z-number) | Z-0543-2010 |
|---|---|
| Recall event | 53771 |
| Product | i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects. |
| Product code | JAK |
| Recalling firm | Imaging Sciences International, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2010 |
| 510(k) numbers | K051980 |
| FEI number | 3021551875 |
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