Recall Z-0052-2018 ยท PBX Massager, Vacuum, Radio Frequency Induced Heat
Bios S.r.l.
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
| Date | Jul 13, 2017 |
| Status | Terminated |
| Reason | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. |
| Root cause | Software design |
| Action | Consignees were sent a recall notification by mail dated 07/13/2017. Customers were notified of the reason for recall and advised that the PAUSE button not be used and the STOP button be used instead to stop the RF emission. Additionally, units are to be connected to the internet so that the BIOS service team can access the units to provide a software update to correct the issue. If a unit cannot be connected to the internet, customers are to contact Thermi to schedule an update. |
| Quantity | 167 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) Bios S.R.L., Nov 19, 2015 |