Device recall
Z-2855-2026: Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version…
FDA device recall · Class II · THERANICA BIOELECTRONICS LTD
Key facts
| Recall number (Z-number) | Z-2855-2026 |
|---|---|
| Recall event | 99307 |
| Product | Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11 |
| Product code | QGT |
| Recalling firm | THERANICA BIOELECTRONICS LTD |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K250405 |
| FEI number | 3015379717 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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