Device recall
Z-0576-2024: The device is a whole-body CT x-ray system. The acquired x-ray transmission data…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-0576-2024 |
|---|---|
| Recall event | 93509 |
| Product | The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and… |
| Product code | JAK |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K180015, K212441 |
| 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