Device recall
Z-3204-2024: SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-3204-2024 |
|---|---|
| Recall event | 95289 |
| Product | SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129 |
| Product code | LNH |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193215, K212673, K213516 |
| FEI number | 3016618143 |
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