Bios S.r.l. recalls THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for select…

Recall date

July 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0052-2018

FDA classification

Class II

Brand / firm

Bios S.r.l.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.