BEUDAMED
    FDA Enforcement Class II Terminated

    McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

    Recall: Z-0042-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0042-2015
    Event ID
    69377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Information Solutions LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    August 27, 2014
    Classification Date
    October 8, 2014
    Termination Date
    May 18, 2016
    Address
    5995 Winward Plaza, Information Technology Business, Alpharetta, GA, 30005, United States

    Description

    McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

    Reason

    Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.

    Code Info

    McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.

    Distribution

    Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel and the United Kingdom.

    Quantity

    272 devices