Reported Nov 8, 2017 · Terminated

THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for…

Bios S.r.l.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bios S.r.l. · Via Guido Rossa 10/12 · Vimodrone, N/A · N/A

Is this the product you have?

  • THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
Lot codes and dates

  • 167 of 167 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
Amount recalled
167 units

Where it was sold

Why it was recalled

In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Where it was distributed

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 15, 2020 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.