FDA-Device2017-04-26Class II

Merge Eye Station and Merge Eye Care PACS.

Merge Healthcare, Inc.
Hazard

During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.

Sold states
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.
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 and Merge Eye Care PACS.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1828-2017

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