THERMI250 Radiofrequency System — Class II medical device recall Z-0052-2018
Terminated recall by Bios S.r.l., reported 2017-11-08, distributed in AR, AZ, CA, FL, GA, ID, IL, KS…. In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
| Recall number | Z-0052-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bios S.r.l., Vimodrone, N/A, Italy |
| Recall initiated | 2017-07-13 |
| Classified | 2017-10-27 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2020-09-15 |
| Distributed | AR, AZ, CA, FL, GA, ID, IL, KS, LA, MA, MI, MO, MS, NJ, NM, NV, NY, OH, OR, PA, SD, TX, WA, WI, WV |
| Countries outside the US | BR, CA, IL, JP, TH |
| Quantity | 167 units |
| Serial numbers | S250-16L-181-2, TS250-16G-081-1, TS250-16G-082-1, TS250-16G-083-1, TS250-16G-084-1, TS250-16G-085-1, TS250-16G-086-1, TS250-16G-087-1, TS250-16G-088-1, TS250-16G-089-1, TS250-16G-090-1, TS250-16G-091-1, TS250-16G-092-1, TS250-16G-093-1, TS250-16G-094-1, TS250-16G-095-1, TS250-16G-096-1, TS250-16G-097-1, TS250-16G-098-1, TS250-16G-099-1, TS250-16G-100-1, TS250-16G-101-1, TS250-16G-102-1, TS250-16G-103-1, TS250-16G-104-1 and 142 more |
Product
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
Reason for recall
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0052-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.