Device recall
Z-1582-2009: Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA…
FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-1582-2009 |
|---|---|
| Recall event | 52214 |
| Product | Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray… |
| Product code | JAK |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class II |
| Status | Terminated on September 24, 2010 |
| 510(k) numbers | K060937 |
| FEI number | 3018004899 |
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