Device recall
Z-1152-2024: Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk…
FDA device recall · Class II · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Key facts
| Recall number (Z-number) | Z-1152-2024 |
|---|---|
| Recall event | 93781 |
| Product | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228… |
| Product code | OWB |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172822, K200917 |
| 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