Recall Z-0052-2018— Bios S.r.l.

Name: FDA recall Z-0052-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-13

Class II · Terminated

Class II FDA medical device recall by Bios S.r.l., initiated 2017-07-13, terminated 2020-09-15. It names one FDA 510(k) clearance: K151296. Product: THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.. Reason: In some systems, the unit continues to emit RF energy after the PAUSE button is pressed..

Recalling firm: Bios S.r.l.
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Terminated: 2020-09-15
Firm location: Vimodrone, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K151296 — Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L.·cleared 2015-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.