FDA recall Z-0052-2018

Product

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

Reason for recall

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

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.

Key facts

Status

Terminated

Initiation date

2017-07-13

Report date

2017-11-08

Termination date

2020-09-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vimodrone, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0052-2018