BEUDAMED
    FDA Recall Terminated

    Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories

    Recall: Z-0082-2012 · Initiated September 23, 2011

    Recall

    Recall Number
    Z-0082-2012
    Event Number
    60054
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 23, 2011
    Posted
    October 21, 2011
    Terminated
    February 16, 2016
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories

    Reason

    HD1200 camera heads may cause image issues

    Action

    Smith Nephew sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated sent September 23, 2011 to all affected consignees. The letter identified the product, problem and actions to be taken. Consignees were instructed to complete requested information, return affected product and order replacement product. To return product and order replacement product, consignees were instructed to contact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to [email protected]. For questions call 405-917-8556.

    Distribution

    Nationwide Distribution (USA) including the states of: MI, NH, OK.

    Quantity

    15 units