BEUDAMED
    FDA Enforcement Class II Terminated

    CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.

    Recall: Z-2742-2015 · Reported September 16, 2015

    Enforcement

    Recall Number
    Z-2742-2015
    Event ID
    71937
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2015
    Initiation Date
    August 7, 2015
    Classification Date
    September 8, 2015
    Termination Date
    May 31, 2016
    Address
    6200 Jackson Rd, N/A, Ann Arbor, MI, 48103-9586, United States

    Description

    CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.

    Reason

    Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.

    Code Info

    500A, 500AHCT, 500AV, 500AVHCT CDI Blood Parameter Monitoring System 500; software version 1.69.

    Distribution

    Worldwide Distribution-US (nationwide) including DC and PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Australia, Belgium, Canada, Chile, Colombia, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates.

    Quantity

    4638