FDA-Device2017-03-01Class II
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Hazard
Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)
Sold states
Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.
Affected count
1,627 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1246-2017Don't want to check this manually?
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