BEUDAMED
    FDA Recall Terminated

    Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000

    Recall: Z-0810-06 · Initiated April 5, 2006

    Recall

    Recall Number
    Z-0810-06
    Event Number
    34948
    Firm
    Macan Engineering and Manufacturing Co., Inc.
    FEI Number
    1418975
    Product Code
    EKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2006
    Posted
    April 27, 2006
    Terminated
    March 24, 2008
    Address
    1564 N Damen Ave, Chicago, IL, 60622-1942

    Description

    Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000

    Reason

    The product label fails to warn users to use the device on patients with shielded pacemakers only.

    Action

    Product recall letters dated 4/5/06 were sent to the distributors, along with recall packages dated 3/23/06, to be sent out to their customers who purchased a MC-4A instrument. The recall packages consist of a customer letter dated 3/23/06, a new warning label - part number 4ALB-001, installation instructions for the label placement, a customer response sheet, and a self-addressed stamped return envelope for the response sheet. The customer letter informs the customers that the old device label lacked adequate information regarding the use of the instrument on patients with pacemakers, and requesting that they place the enclosed label with the required warnings on the device, and complete and return the response sheet.

    Distribution

    Nationwide and Canada

    Quantity

    455 units