Device recall
Z-2595-2025: Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-2595-2025 |
|---|---|
| Recall event | 97468 |
| Product | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317 |
| Product code | JAK |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K033326 |
| FEI number | 3016618143 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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