Device recall
Z-2358-2025: C8-4v Transducer Probe
FDA device recall · Class III · Philips Ultrasound, Inc
Key facts
| Recall number (Z-number) | Z-2358-2025 |
|---|---|
| Recall event | 97217 |
| Product | C8-4v Transducer Probe |
| Product code | IYN |
| Recalling firm | Philips Ultrasound, Inc |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K030455, K034003, K043535, K081661 |
| FEI number | 2518586 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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