FDA Device recall Z-0052-2018
THERMI250 Radiofrequency System
- FDA Device
- Class II
- terminated
- Published 2017-11-08
On 2017-11-08 the FDA classified a Class II recall of THERMI250 Radiofrequency System by Bios S R L, citing in some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0052-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-13 |
| Published | 2017-11-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bios S R L |
| Distribution | 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 |
Product
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
Reason
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Identifiers
| code_info | Serial No. TS250-16G-088-1, TS250-16G-089-1, TS250-16G-090-1, TS250-16G-094-1, TS250-16G-097-1, TS250-16G-098-1, TS250-…Serial No. TS250-16G-088-1, TS250-16G-089-1, TS250-16G-090-1, TS250-16G-094-1, TS250-16G-097-1, TS250-16G-098-1, TS250-16G-106-1, TS250-16G-109-2, TS250-16I-116-1, TS250-16I-120-1, TS250-16I-121-1, TS250-16I-122-1, TS250-16I-123-1, TS250-16I-124-1, TS250-16I-127-1, TS250-16I-128-1, TS250-16I-129-1, TS250-16I-130-1, TS250-16I-134-1, TS250-16I-135-1, TS250-16I-136-1, TS250-16I-137-1, TS250-16I-140-1, TS250-16I-142-1, TS250-16I-146-2, TS250-16L-156-1, TS250-16L-158-1, TS250-16L-159-1, TS250-16L-160-1, TS250-16L-164-1, TS250-16L-165-1, TS250-16L-167-1, TS250-16L-168-1, TS250-16L-169-1, TS250-16L-170-1, TS250-16L-177-1, TS250-16L-178-1, TS250-16L-179-1, TS250-16N-190-1, TS250-16N-191-1, TS250-16N-192-1, TS250-16N-194-1, TS250-16N-195-1, TS250-16N-197-1, TS250-16N-198-1, TS250-16N-199-1, TS250-16N-202-1, TS250-16N-203-1, TS250-16N-204-1, TS250-16N-205-1, TS250-16N-207-1, TS250-16N-208-1, TS250-16N-209-1, TS250-16N-210-1, TS250-16N-211-1, TS250-16N-213-1, TS250-16N-214-1, TS250-16N-215-1, TS2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0052-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.