BEUDAMED
    FDA Recall Terminated

    OPERON D850 Surgical Table Product Usage: Surgical Table

    Recall: Z-2168-2013 · Initiated April 16, 2012

    Recall

    Recall Number
    Z-2168-2013
    Event Number
    65960
    Firm
    Berchtold Corp.
    FEI Number
    1220685
    Product Code
    GDC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 16, 2012
    Posted
    September 9, 2013
    Terminated
    September 10, 2013
    Address
    1950 Hanahan Rd N, Charleston, SC, 29406-4878

    Description

    OPERON D850 Surgical Table Product Usage: Surgical Table

    Reason

    Table was not lowering.

    Action

    Berchtold sent a Customer Notification letter dated April 16, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that BERCHTOLD will upgrade the OPERON Surgical tables with a new firmware version that will eliminate the potential for experiencing problems. For questions call 843-569-6100 ext. 322.

    Distribution

    USA Nationwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, HI.IL, IA, KY, LA, MD, MA, MI, MN, MS, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WI and including Canada.

    Quantity

    263