FDADecember 20, 2018device
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 imagin...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Terminated
Brands named
merge healthcaremerge
UPCs
00842000100140
Recall history
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