BEUDAMED
    FDA Recall Terminated

    Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.

    Recall: Z-2754-2017 · Initiated June 13, 2017

    Recall

    Recall Number
    Z-2754-2017
    Event Number
    77627
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    NFJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 13, 2017
    Posted
    July 10, 2017
    Terminated
    September 17, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.

    Reason

    When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.

    Action

    The firm initiated the recall by certified letter the week of 06/26/2017. The notice provided the work-around and requested a response.

    Distribution

    FL, IL, CO, MI, CA, NY, ND, OH, CT

    Quantity

    18 units