| Class 2 Device Recall THERMI250 Radiofrequency System |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = PBX
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