BEUDAMED
    FDA Recall Terminated

    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems

    Recall: Z-3105-2017 · Initiated August 14, 2017

    Recall

    Recall Number
    Z-3105-2017
    Event Number
    77811
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 14, 2017
    Posted
    August 18, 2017
    Terminated
    May 8, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems

    Reason

    The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

    Action

    MERGE sent a Medical Device Recall letter dated August 11, 2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to [email protected]. For questions regarding this recall call 262-912-3514.

    Distribution

    Nationwide Distribution

    Quantity

    98 sites have the potentially affected software