Device recall
Z-2404-2012: The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body…
FDA device recall · Class III · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-2404-2012 |
|---|---|
| Recall event | 63006 |
| Product | The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. |
| Product code | JAK |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 24, 2013 |
| 510(k) numbers | K012009 |
| FEI number | 1525965 |
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