BEUDAMED
    FDA Recall Terminated

    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

    Recall: Z-1463-2014 · Initiated March 20, 2014

    Recall

    Recall Number
    Z-1463-2014
    Event Number
    67835
    Firm
    Solta Medical, Inc.
    FEI Number
    3003079710
    Product Code
    ONG
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 20, 2014
    Posted
    April 16, 2014
    Terminated
    April 27, 2015
    Address
    25881 Industrial Blvd, Hayward, CA, 94545-2991

    Description

    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

    Reason

    Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.

    Action

    Solta Medical sent an Correction Important Product letter dated March 20, 2014 to affected customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form.

    Distribution

    Worldwide distribution

    Quantity

    1077 units