BEUDAMED
    FDA Recall Terminated

    SMARTABLATE RF System Generator

    Recall: Z-0210-2018 · Initiated June 14, 2017

    Recall

    Recall Number
    Z-0210-2018
    Event Number
    77575
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 14, 2017
    Terminated
    January 11, 2021
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    SMARTABLATE RF System Generator

    Reason

    Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.

    Action

    All new U.S. and OUS customers, who have purchased the SMARTABLATE" Generator system since the launch of the original field action in March 2015 to the time the IFU was updated in November 2015, will be notified. The previously distributed Field Safety Notification Letter for the SMARTABLATE" Generator (Part Numbers# M490006 and M490007) and customer Acknowledgement Form will be sent to these new customers. Instructions included review the Field Safety Notice carefully, provide the notice to appropriate personnel in facility, ensure the SMARTABLATE System Foot Pedal is not located within the Stereotaxis RMT Lab, complete and return the Acknowledgement Forms, and maintain awareness of the notice.

    Distribution

    Distributed to the following states: CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI. Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.

    Quantity

    185 units total