BEUDAMED
    FDA Recall 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 · Initiated August 27, 2014

    Recall

    Recall Number
    Z-0042-2015
    Event Number
    69377
    Firm
    Mckesson Information Solutions LLC
    FEI Number
    3002684279
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    August 27, 2014
    Posted
    October 8, 2014
    Terminated
    May 18, 2016
    Address
    5995 Winward Plaza, Information Technology Business Alpharetta, GA, 30005

    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.

    Action

    On August 27, 2014, McKesson initiated a correction via a Field Safety Notice to all affected domestic customers. McKesson Israel will be responsible for contacting foreign consignees.

    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