Class II — Bios S.r.l.
| Recalling firm | BIOS |
|---|---|
| Registered facility | BIOS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. |
| Product | THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions. |
| Quantity | 167 units |
| Distribution | AZ, AR, CA, FL, GA, ID, IL, KS, LA, MA, MI, MS, MO, NV, NJ, NM, NY, OH, OR, PA, SD, TX, WA, WI, and WV Brazil, Canada, Israel, Japan, & Thailand. |
| Initiated | 2017-07-13 |
| Classified | 2017-10-27 |
| Terminated | 2020-09-15 |
| Recall number | Z-0052-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bios S.r.l. (Z-0052-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77754/
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