BEUDAMED
    FDA Recall Terminated

    EM2+A NC AEM Monotor (NON-COM)

    Recall: Z-1051-03 · Initiated June 23, 2003

    Recall

    Recall Number
    Z-1051-03
    Event Number
    26604
    Firm
    Encision, Inc.
    FEI Number
    1000117361
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 23, 2003
    Posted
    July 24, 2003
    Terminated
    November 6, 2003
    Address
    4828 Sterling Drive, Boulder, CO, 80301

    Description

    EM2+A NC AEM Monotor (NON-COM)

    Reason

    Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.

    Action

    Accounts were visited by sales representatives beginning 6/23/2003.

    Distribution

    CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.

    Quantity

    4 units