BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0052-2018 · Initiated July 13, 2017

    Recall

    Recall Number
    Z-0052-2018
    Event Number
    77754
    Firm
    Bios S.r.l. Via Guido Rossa 10/12 Vimodrone Italy
    FEI Number
    3008108972
    Product Code
    PBX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 13, 2017
    Terminated
    September 15, 2020

    Description

    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.

    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.

    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.

    Quantity

    167 units