Device recall
Z-0035-2025: Patient Information Center iX, Product Code 866386, and Patient Information…
FDA device recall · Class II · Philips North America
Key facts
| Recall number (Z-number) | Z-0035-2025 |
|---|---|
| Recall event | 95325 |
| Product | Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1 |
| Product code | DSI |
| Recalling firm | Philips North America |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K113125, K153702 |
| FEI number | 3006648320 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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