Device recall
Z-2315-2021: Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-2315-2021 |
|---|---|
| Recall event | 88336 |
| Product | Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system |
| Product code | JAK |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2023 |
| 510(k) numbers | K160743 |
| 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