Device recall
Z-1326-2013: Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-1326-2013 |
|---|---|
| Recall event | 65028 |
| Product | Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency… |
| Product code | JAA |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2014 |
| 510(k) numbers | K051025 |
| FEI number | 1221300 |
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