Z-0939-2019Class II

The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System

Name: Z-0939-2019 The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System
Creator: Merge Healthcare, Inc.
Published: 2018-12-20
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2018-12-20 / Terminated / root cause: design

FDA source

Merge Healthcare, Inc. began a recall of 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... on 2018-12-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0939-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-20
Posted: 2019-02-25
Terminated: 2023-02-28
Recalling firm: Merge Healthcare Incorporated
Product: 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.
Product code: HKI Camera, Ophthalmic, Ac-Powered
Reason for recall: 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).
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 1,252 Units
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 codes and lots: UDI: 00842000100140. 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0939-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0939-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25

Product code HKI

K982689Class IIWinstation Retinal ImagerOphthalmic Imaging Systems / cleared 1998-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)