ClearanceBrief
Recall Z-0939-2019 ยท HKI Camera, Ophthalmic, Ac-Powered

Merge Healthcare, Inc.

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-inv

DateFeb 25, 2019 (initiated Dec 20, 2018)
StatusTerminated
ReasonCertain 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 causeDevice Design
ActionOn 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 representativ
Quantity1,252 Units
DistributionDistribution 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, Nebras
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K982689WINSTATION RETINAL IMAGER
Ophthalmic Imaging Systems, Oct 23, 1998