BEUDAMED
    FDA Enforcement Class II Terminated

    McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.

    Recall: Z-0910-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0910-2015
    Event ID
    70144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    McKesson Israel Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    January 5, 2015
    Termination Date
    February 25, 2016
    Address
    4 Nehoshet St., or Towers, Bldg. B, Tel Aviv, N/A, N/A, Israel

    Description

    McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.

    Reason

    An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.

    Code Info

    MC13.1 and MC13.1.1

    Distribution

    Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.

    Quantity

    9