Device recall
Z-0497-2025: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software…
FDA device recall · Class II · Philips Medical Systems Technologies Ltd.
Key facts
| Recall number (Z-number) | Z-0497-2025 |
|---|---|
| Recall event | 95604 |
| Product | Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites. |
| Product code | LLZ |
| Recalling firm | Philips Medical Systems Technologies Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K110919, K153103 |
| FEI number | 3015763655 |
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