BEUDAMED
    FDA Recall 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 · Initiated June 25, 2014

    Recall

    Recall Number
    Z-0093-2015
    Event Number
    69380
    Firm
    Mckesson Information Solutions LLC
    FEI Number
    3002684279
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 25, 2014
    Posted
    October 20, 2014
    Terminated
    October 26, 2017
    Address
    5995 Winward Plaza, Information Technology Business Alpharetta, GA, 30005

    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

    Action

    Consignees were notified via Field Safety Notice on 06/25/2014.

    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