FDA-Device2017-04-05Class II
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Merge Healthcare, Inc.
Hazard
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Sold states
Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.
Affected count
1,627 sites potentially have the affected software
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1681-2017Don't want to check this manually?
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