Device recall
Z-0052-2018: THERMI250 Radiofrequency System. Intended to provide heating for the purpose of…
FDA device recall · Class II · Bios S.r.l.
Key facts
| Recall number (Z-number) | Z-0052-2018 |
|---|---|
| Recall event | 77754 |
| Product | THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions. |
| Product code | PBX |
| Recalling firm | Bios S.r.l. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2020 |
| 510(k) numbers | K151296 |
| FEI number | 3008108972 |
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