BEUDAMED
    FDA Recall Terminated

    Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

    Recall: Z-1778-2017 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1778-2017
    Event Number
    76859
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2016
    Posted
    April 11, 2017
    Terminated
    February 21, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

    Reason

    Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

    Action

    MERGE sent an Urgent Medical Device Recall letter dated April 4, 2016 to all affected customers via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all users of the affected product be provided with the notice. Customers were also asked to reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to [email protected]. For questions regarding this recall call 877-741-5369.

    Distribution

    Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.

    Quantity

    24 sites potentially have the affected versions