Device recall
Z-0806-2025: EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS…
FDA device recall · Class II · Elucent Medical Inc
Key facts
| Recall number (Z-number) | Z-0806-2025 |
|---|---|
| Recall event | 95902 |
| Product | EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time… |
| Product code | NEU |
| Recalling firm | Elucent Medical Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183400 |
| FEI number | 3014653199 |
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