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Terminated

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

FDA Recall Z-0052-2018 · Posted None

Recalling FirmBios S.r.l.
Recall StatusTerminated
Product CodePBX
Date Initiated2017-07-13
Date Terminated2020-09-15
Product Quantity167 units

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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