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.

FDA Recall Z-0939-2019 · Posted 2019-02-25

Recalling FirmMerge Healthcare, Inc.

Recall StatusTerminated

Product CodeHKI

Date Initiated2018-12-20

Date Terminated2023-02-28

Product Quantity1,252 Units

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).

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982689WINSTATION RETINAL IMAGEROphthalmic Imaging Systems · 1998-10-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.