BEUDAMED
    FDA Recall Terminated

    DR Systems Unity PACS software, now known as Merge Unity PACS software.

    Recall: Z-0939-2017 · Initiated October 15, 2015

    Recall

    Recall Number
    Z-0939-2017
    Event Number
    75876
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 15, 2015
    Terminated
    April 23, 2021
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    DR Systems Unity PACS software, now known as Merge Unity PACS software.

    Reason

    The software fails to associate to the correct MG image if there are two images for the same view.

    Action

    Merge sent an Urgent : Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Be aware of the following workaround: Customer I User: Ensure both" tome" images are reviewed when more than one is captured for the same view. Merge has a released fix available for this issue. YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED Please reply using the enclosed form and the return addressed envelope. Your response is required no later than August 2,2016. For further questions regarding this recall please call (877) 741-5369

    Distribution

    Distribution was made to medical facilities located in MT, CA, PA, and TX.

    Quantity

    9 sites potentially have the effected software