BEUDAMED
    FDA Recall Terminated

    Esaote brand ArchiWin Colour ECG System; part 9704325000.

    Recall: Z-0534-04 · Initiated December 23, 2003

    Recall

    Recall Number
    Z-0534-04
    Event Number
    27980
    Firm
    Esaote Biomedica S.P.A. c/o The Anson Group
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 23, 2003
    Posted
    July 20, 2004
    Terminated
    October 28, 2004
    Address
    7992 Castleway Drive, Indianapolis, IN, 46250-1943

    Description

    Esaote brand ArchiWin Colour ECG System; part 9704325000.

    Reason

    If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.

    Action

    A recall letter dated December 23, 2003 was sent to distributors asking them for contact information for affected customers. Esaote will the provide the user customers with an addendum to the users manual until a software upgrade becomes available and is installed.

    Distribution

    California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.

    Quantity

    1