BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0093-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0093-2015
    Event ID
    69380
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Information Solutions LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    June 25, 2014
    Classification Date
    October 20, 2014
    Termination Date
    October 26, 2017
    Address
    5995 Winward Plaza, Information Technology Business, Alpharetta, GA, 30005, United States

    Description

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

    Reason

    McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i

    Code Info

    McKesson Cardiology TM Hemo versions: 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, 12.2HF4.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.

    Quantity

    625 devices