BEUDAMED
    FDA Recall Terminated

    Merge HEMO software.

    Recall: Z-2341-2016 · Initiated July 2, 2012

    Recall

    Recall Number
    Z-2341-2016
    Event Number
    74577
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 2, 2012
    Posted
    August 4, 2016
    Terminated
    June 26, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge HEMO software.

    Reason

    The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

    Action

    The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response.

    Distribution

    The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.

    Quantity

    37