Device recall
Z-0041-2008: PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET…
FDA device recall · Class III · Naviscan PET Systems
Key facts
| Recall number (Z-number) | Z-0041-2008 |
|---|---|
| Recall event | 44791 |
| Product | PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging. |
| Product code | KPS |
| Recalling firm | Naviscan PET Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 14, 2008 |
| 510(k) numbers | K032063 |
| FEI number | 3005945241 |
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