Device recall
Z-2314-2021: 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-2314-2021 |
|---|---|
| Recall event | 88336 |
| Product | 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades |
| Product code | JAK |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2023 |
| 510(k) numbers | K162838 |
| FEI number | 3016618143 |
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