Device recall
Z-3015-2011: Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-3015-2011 |
|---|---|
| Recall event | 59398 |
| Product | Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel, but at times are used for non medical applications… |
| Product code | JAA |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2012 |
| 510(k) numbers | K843920 |
| 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