device · product 1 of 1
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
- Recall number
- Z-0052-2018
- Initiated
- July 13, 2017
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Bios S.r.l.
- Quantity
- 167 units
App-derived interpretation
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Official device-enrichment evidence · Sourced
Software design
Inspect official wording and provenance
Reason for recall
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Code information
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, TS250-16N-216-1, TS250-16N-217-1, TS250-16N-219-1, TS250-16N-220-1, TS250-16N-223-1, TS250-16N-224-1, TS250-17B-229-1, TS250-17B-230-1, TS250-17B-231-1, TS250-17B-239-1, TS250-17B-243-1, TS250-17B-247-1, TS250-17B-249-1, TS250-17B-250-1, TS250-16L-153-1, TS250-16L-180-2, TS250-16N-212-1, TS250-17B-225-1, TS250-17B-226-1, TS250-17B-228-1, TS250-17B-232-1, TS250-17B-233-1, TS250-17B-234-1, TS250-17B-242-1, TS250-17B-245-1, TS250-16G-093-1, TS250-16G-104-1, TS250-16L-182-2, TS250-17B-235-1, TS250-17B-236-1, TS250-17B-237-1, TS250-17B-238-1, TS250-17B-244-1, TS250-16I-112-2, TS250-16I-113-2, TS250-16I-114-2, TS250-16I-115-2, TS250-16G-100-1, 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-091-1, TS250-16G-092-1, TS250-16G-095-1, TS250-16G-096-1, TS250-16G-099-1, TS250-16G-101-1, TS250-16G-102-1, TS250-16G-103-1, TS250-16G-105-1, TS250-16G-107-1, TS250-16H-110-2, TS250-16I-117-1, TS250-16I-118-1, TS250-16I-119-1, TS250-16I-125-1, TS250-16I-126-1, TS250-16I-131-1, TS250-16I-132-1, TS250-16I-133-1, TS250-16I-138-1, TS250-16I-139-1, TS250-16I-141-1, TS250-16I-143-1, TS250-16I-144-2, TS250-16I-145-2, TS250-16I-147-2, TS250-16L-155-1, TS250-16L-176-1, TS250-16L-183-2, TS250-16N-193-1, TS250-16N-196-1, TS250-16N-200-1, TS250-16N-201-1, TS250-16N-206-1, TS250-16N-218-1, TS250-16N-222-1, TS250-17B-227-1, TS250-17B-240-1, TS250-17B-241-1, TS250-17B-246-1, TS250-17B-248-1, TS250-17B-251-1, TS250-17B-252-1, TS250-17B-253-1, TS250-17B-254-1, TS250-17B-255-1, TS250-17B-256-1, TS250-17B-257-1, TS250-17B-258-1, TS250-17B-259-1, TS250-17B-260-1, TS250-16H-108-2, TS250-16L-148-1, TS250-16L-149-1, TS250-16L-150-1, TS250-16L-151-1, TS250-16L-152-1, TS250-16L-157-1, S250-16L-181-2, TS250-16L-184-1, TS250-16L-185-1, TS250-16L-186-1, TS250-16L-187-1, and TS250-16L-188-1
Distribution pattern
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.