BEUDAMED
    FDA Recall Terminated

    Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.

    Recall: Z-2148-2012 · Initiated July 10, 2012

    Recall

    Recall Number
    Z-2148-2012
    Event Number
    62683
    Firm
    Berchtold Corp.
    FEI Number
    1220685
    Product Code
    FWH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 10, 2012
    Posted
    August 6, 2012
    Terminated
    June 6, 2013
    Address
    1950 Hanahan Rd N, Charleston, SC, 29406-4878

    Description

    Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.

    Reason

    Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss.

    Action

    BERCHTOLD Corporation sent a letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. BERCHTOLD will replace the customer's cameras at no cost to the customer. Customers with questions should call 843-569-6100, ext 322. For questions regarding this recall call 843-569-6100.

    Distribution

    Nationwide Distribution including FL, MI, MS, and NH.

    Quantity

    17 cameras