BEUDAMED
    FDA Recall Terminated

    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.

    Recall: Z-0750-2013 · Initiated January 9, 2013

    Recall

    Recall Number
    Z-0750-2013
    Event Number
    63875
    Firm
    Envoy Medical Corporation
    FEI Number
    3004007782
    Product Code
    OAF
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 9, 2013
    Posted
    January 30, 2013
    Terminated
    April 9, 2013
    Address
    5000 Township Parkway, Saint Paul, MN, 55110

    Description

    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.

    Reason

    Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.

    Action

    Envoy Medical Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-233-1204 for questions relating to this notice.

    Distribution

    Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.

    Quantity

    44