BEUDAMED
    FDA Recall Terminated

    The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.

    Recall: Z-0939-2019 · Initiated December 20, 2018

    Recall

    Recall Number
    Z-0939-2019
    Event Number
    81869
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    HKI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 20, 2018
    Posted
    February 25, 2019
    Terminated
    February 28, 2023
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.

    Reason

    Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground).

    Action

    On about 12/20/2018 Merge Healthcare notified customers via "Urgent Field Safety Notice." The notice informed customers that certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. A leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground). Instructions included to immediately cease use of all Eye Station hardware and that a Merge Healthcare representative will contact each customer to schedule a correction once the modification is available. Questions regarding the recall notification can be directed to customer support at [email protected] or 877-741-5369.

    Distribution

    Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, , Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West , Virginia, Wisconsin. International distribution to Algeria, Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Israel, Netherlands, Puerto Rico, United Kingdom.

    Quantity

    1,252 Units