FDA Medical Device Recalls (openFDA)
Bios S.r.l.: THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
- Recall number
- Z-0052-2018
- Recalling firm
- Bios S.r.l.
- Product
- THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
- Status
- Terminated
- Initiated
- 2017-07-13
- Posted
- not on file
- Terminated
- 2020-09-15
- Reason
- In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
- Root cause
- Software design
- Action
- Consignees were sent a recall notification by mail dated 07/13/2017. Customers were notified of the reason for recall and advised that the PAUSE button not be used and the STOP button be used instead to stop the RF emission. Additionally, units are to be connected to the internet so that the BIOS service team can access the units to provide a software update to correct the issue. If a unit cannot be connected to the internet, customers are to contact Thermi to schedule an update.
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K151296"]
- PMA numbers
- not on file
- Product code
- PBX
- Firm FEI
- 3008108972
- Firm city
- Vimodrone
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28