Device recall
Z-1997-2019: Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
FDA device recall · Class II · Philips Medical Systems Nederlands
Key facts
| Recall number (Z-number) | Z-1997-2019 |
|---|---|
| Recall event | 83366 |
| Product | Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 |
| Product code | OWB |
| Recalling firm | Philips Medical Systems Nederlands |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2024 |
| 510(k) numbers | K172822 |
| FEI number | 3002807880 |
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