BEUDAMED
    FDA Recall Terminated

    Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

    Recall: Z-0018-05 · Initiated September 24, 2004

    Recall

    Recall Number
    Z-0018-05
    Event Number
    30145
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    NWI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2004
    Posted
    October 13, 2004
    Terminated
    September 15, 2005
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

    Reason

    Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.

    Action

    Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.

    Distribution

    Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.

    Quantity

    19