BEUDAMED
    FDA Recall Terminated

    Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System

    Recall: Z-0578-05 · Initiated January 5, 2005

    Recall

    Recall Number
    Z-0578-05
    Event Number
    30792
    Firm
    Sybaritic, Inc
    FEI Number
    2131125
    Product Code
    IMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2005
    Posted
    March 9, 2005
    Terminated
    February 7, 2007
    Address
    9220 James Ave S, Bloomington, MN, 55431-2302

    Description

    Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System

    Reason

    Device is performing functions that are not cleared in the 510(k).

    Action

    The firm initiated the recall procedure 01/05/05. A phone call is made to each facility which has a dermosonic machine. The phone call serves the purpose of telling the customer that their dermosonic machine needs a programming chip replaced, the manual updated and a 'caution' sticker be placed on the machine. An employee of Computer Repair.com then contacts the customer to set up a time to replace the programming chip and manual, and place a 'caution' sticker on the machine.

    Distribution

    AZ, CA, CO, CT, FL, GA, ID, IL, IA, KS, LA, MA, MI, MN, NV, NJ, NM, NY, NC, OH, OK, OR, SC, SD, TN, TX, UT, VA & WI and to the Phillipines

    Quantity

    185 units