Device recall
Z-1583-2025: Zenition 70. The device is to be used in health care facilities both inside and…
FDA device recall · Class II · Philips Medical Systems Nederland B.V.
Key facts
| Recall number (Z-number) | Z-1583-2025 |
|---|---|
| Recall event | 96598 |
| Product | Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. |
| Product code | OWB |
| Recalling firm | Philips Medical Systems Nederland B.V. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183040, K212813 |
| FEI number | 3000976525 |
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