Device recall
Z-0284-2025: Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a…
FDA device recall · Class II · Canon Medical System, USA, INC.
Key facts
| Recall number (Z-number) | Z-0284-2025 |
|---|---|
| Recall event | 95471 |
| Product | Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. |
| Product code | KPS |
| Recalling firm | Canon Medical System, USA, INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K231748 |
| FEI number | 2020563 |
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