FDAJuly 13, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

bios s r lbios

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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