BEUDAMED
    FDA Recall Terminated

    Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature , and gases (i.e. five anesthetsia gases, O2, N2O, and CO2)

    Recall: Z-0177-06 · Initiated September 7, 2005

    Recall

    Recall Number
    Z-0177-06
    Event Number
    33724
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    DRT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 7, 2005
    Posted
    November 23, 2005
    Terminated
    June 6, 2007
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature , and gases (i.e. five anesthetsia gases, O2, N2O, and CO2)

    Reason

    Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.

    Action

    Datascope sent out a Field Correction notice on 9/7/2005 to all Hospital administrators who have the monitors. This was sent out via certified mail, return receipt requested. A Datascope Service Rep will conduct and document the corrective action during a visit to the customer.

    Distribution

    The monitors have been distributed domestically and internationally to hospitals and clinics. There are 10 Passport 2 monitors distributed to Naval Hospital, Camp Pendleton, CA. There are 12 Spectrum monitors distributed to two US Govt facilities: VA Medical Center, Hines, IL and VA Medical Center, Syracuse, NY.

    Quantity

    979 monitors