BEUDAMED
    FDA Recall Terminated

    MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 Intended use: Treatment of primary axillary hyperhidrosis.

    Recall: Z-2591-2011 · Initiated April 24, 2011

    Recall

    Recall Number
    Z-2591-2011
    Event Number
    58853
    Firm
    Miramar Labs, Inc.
    FEI Number
    3008082710
    Product Code
    OUB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 24, 2011
    Posted
    June 17, 2011
    Terminated
    June 17, 2011
    Address
    445 Indio Way, Sunnyvale, CA, 94085-4203

    Description

    MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 Intended use: Treatment of primary axillary hyperhidrosis.

    Reason

    Reports of skin burns on axilla after treatment with the miraDry System.

    Action

    The firm,Miramar, has a service provider in Japan that assists in dealing with customers. The service providers were provided a copy of the investigation report and communicated directly with the customers to set up appointments for the field correction. The customers were personally visited by a representative from Miramars service provider in Japan. All devices had field correction performed on April 26-28, 2011.

    Distribution

    International only: Japan

    Quantity

    8 units