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Bios S.r.l. recalls THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for sele
Recalled November 8, 2017 · FDA recall Z-0052-2018 · Bios S.r.l
Hazard
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. · FDA Class II
Units
167 units
Sold at
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.
Description
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Product
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
Manufacturer(s)
Bios S.r.l.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →