FDA-Device2017-01-11Class II
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Merge Healthcare, Inc.
Hazard
The software fails to associate to the correct MG image if there are two images for the same view.
Sold states
Distribution was made to medical facilities located in MT, CA, PA, and TX.
Affected count
9 sites potentially have the effected software
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0939-2017Don't want to check this manually?
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