Device recall
Z-2297-2025: 3mensio Workstation (Vascular Fenestrated) software
FDA device recall · Class II · PIE Medical Imaging B.V.
Key facts
| Recall number (Z-number) | Z-2297-2025 |
|---|---|
| Recall event | 97307 |
| Product | 3mensio Workstation (Vascular Fenestrated) software |
| Product code | LLZ |
| Recalling firm | PIE Medical Imaging B.V. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K153736 |
| FEI number | 3003595527 |
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