The WinStation Retinal Imager, also known as Merge Eye… recallZ-0939-2019 · Merge Healthcare, Inc. · initiated Dec 20, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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).

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number: Z-0939-2019
Status: Terminated
Initiated by the company: Dec 20, 2018
Posted by the FDA: Feb 25, 2019
Recalling firm: Merge Healthcare, Inc.
Quantity: 1,252 Units
Product code: HKI
FDA submissions: K982689
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.

Product 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.

Code information (models, lots, serial numbers)

Show the full code information (21k characters)

UDI: 00842000100140. 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Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Merge Eye Station 11.6.1
Merge Healthcare Solutions Inc. · System, Image Management, Ophthalmic
1 recall1 report

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page