BEUDAMED
    FDA Recall Terminated

    Image Consultant (IC) Software

    Recall: Z-1176-2010 · Initiated February 5, 2010

    Recall

    Recall Number
    Z-1176-2010
    Event Number
    54633
    Firm
    R.O. Gulden & Co., Inc.
    FEI Number
    2518410
    Product Code
    NFF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 5, 2010
    Posted
    March 22, 2010
    Terminated
    June 14, 2010
    Address
    225 Cadwalader Ave, Elkins Park, PA, 19027-2020

    Description

    Image Consultant (IC) Software

    Reason

    Software not validated; inaccurate results may occur.

    Action

    On 2/5/10, the recalling firm issued letters via certified mail to its consignees informing them of the problem and to cease use of the software for diagnosis.

    Distribution

    The product was shipped to eye doctors/clinics in AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, and WA.

    Quantity

    20