BEUDAMED
    FDA Recall Terminated

    PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma

    Recall: Z-2123-2014 · Initiated June 30, 2014

    Recall

    Recall Number
    Z-2123-2014
    Event Number
    68706
    Firm
    Ra Medical Systems Inc
    FEI Number
    3004217728
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 30, 2014
    Posted
    July 28, 2014
    Terminated
    September 9, 2014
    Address
    1930 Kellogg Ave, Carlsbad, CA, 92008-6581

    Description

    PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma

    Reason

    RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed.

    Action

    Ra Medical Systems sent a customer letter dated June 30, 2014, to who purchased the PHAROS EX-308 Excimer Laser Phototherapy System Hand Piece. The letter informed the customers of the problems identified and the actions to be taken. Customers were also provided with the Instructions for Use (IFU) for the PHAROS EX-308 Excimer Laser Phototherapy System Hand Piece and a replacement iris indication label for the handpiece.

    Distribution

    Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia.

    Quantity

    435 units