Device recall
Z-1580-2025: Zenition 50. Product Code 718096. The devices are used for radiological guidance…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-1580-2025 |
|---|---|
| Recall event | 96593 |
| Product | Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices. |
| Product code | OWB |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183101 |
| FEI number | 3016618143 |
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