Bios THERMI250 Radiofrequency System: RF Energy Continues After Pause Button Pressed
Bios recalls THERMI250 radiofrequency systems that emit RF energy after pause button is pressed. Affected units have specific serial numbers. Users should stop using immediately to prevent potential tissue damage.
Stop using this now
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Contact the company
What happened, in plain English
Bios is recalling THERMI250 radiofrequency systems that continue emitting RF energy even after the pause button is pressed. This could cause unintended tissue heating and potential injury if the device is left on during medical procedures. Read more at govinfonow.com/recall/73432-bios-thermi250-radiofrequency-system-rf-energy-continues-after-pause-button.
Source Summary by GovInfoNow · govinfonow.com/recall/73432-bios-thermi250-radiofrequency-system-rf-energy-continues-after-pause-button · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0052-2018
Cite this page
“Bios THERMI250 Radiofrequency System: RF Energy Continues After Pause Button Pressed.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73432-bios-thermi250-radiofrequency-system-rf-energy-continues-after-pause-button. Based on FDA recall #Z-0052-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0052-2018%22&limit=1).
Why it’s dangerous
The device continues emitting radiofrequency (RF) energy after the pause button is pressed, which can cause unintended tissue heating. This risk is particularly concerning during medical procedures where precise control over temperature is critical.
Who’s affected
Medical professionals using the THERMI250 system for tissue heating procedures are most at risk. Patients receiving treatments with affected units may also be exposed to unintended RF energy.
How to tell if you have this one
Check if your THERMI250 system has a serial number starting with TS250-16G, TS250-16I, TS250-16L, or TS250-16N followed by specific numbers listed in the recall notice.
- Brand
Bios- Category
Medical device
What to do — step by step
Stop Using Immediately
Discontinue use of the THERMI250 system if it has a serial number listed in the recall notice to prevent unintended tissue heating.
Where it went and when
Where it was distributed
Distributed in 25 states, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, California, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0052-2018 (July 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0052-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.