BEUDAMED
    FDA Enforcement Class II Terminated

    Horizon Cardiology Hemo

    Recall: Z-1489-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1489-2019
    Event ID
    82600
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Change Healthcare Israel Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 5, 2019
    Initiation Date
    March 25, 2019
    Classification Date
    May 24, 2019
    Termination Date
    March 4, 2025
    Address
    26, Ha-Rokmim, N/A, Holon, N/A, N/A, Israel

    Description

    Horizon Cardiology Hemo

    Reason

    users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician s Report as well as customers, who have implemented an outbound interface of procedure results.

    Code Info

    Software version 11.x and 12.x

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WY. International distribution to Australia, Canada, Germany, Ireland, Israel, United Kingdom.

    Quantity

    125 devices