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U.S. Department of Health and Human Services

Class 2 Device Recall THERMI250 Radiofrequency System

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  Class 2 Device Recall THERMI250 Radiofrequency System see related information
Date Initiated by Firm July 13, 2017
Create Date October 27, 2017
Recall Status1 Terminated 3 on September 15, 2020
Recall Number Z-0052-2018
Recall Event ID 77754
510(K)Number K151296  
Product Classification Massager, vacuum, radio frequency induced heat - Product Code PBX
Product THERMI250 Radiofrequency System.

Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
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 
Recalling Firm/
Manufacturer
Bios S.r.l.
Via Guido Rossa 10/12
Vimodrone Italy
Manufacturer Reason
for Recall
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PBX and Original Applicant = BIOS S.R.L.
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