BEUDAMED
    FDA Recall Terminated

    Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.

    Recall: Z-1423-2009 · Initiated June 18, 2008

    Recall

    Recall Number
    Z-1423-2009
    Event Number
    51716
    Firm
    Sybaritic, Inc
    FEI Number
    2131125
    Product Code
    ISA
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    June 18, 2008
    Posted
    June 23, 2009
    Terminated
    July 6, 2012
    Address
    9220 James Ave S, Bloomington, MN, 55431-2302

    Description

    Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.

    Reason

    Misbranded and sale without pre-market notification.

    Action

    Sybaritic sent a letter to the consignee on June 18, 2008. The letter confirmed their phone conversation on June 16 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA.

    Distribution

    UT

    Quantity

    1