Device recall
Z-3018-2011: i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that…
FDA device recall · Class II · Imaging Sciences International, LLC
Key facts
| Recall number (Z-number) | Z-3018-2011 |
|---|---|
| Recall event | 57583 |
| Product | i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, 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 | Mar 1, 2013 |
| 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