FDA-Device2017-03-15Class II
DR Systems Unity PACS software, now known as Merge Unity PACS
Merge Healthcare, Inc.
Hazard
Reports were missing demographic header information when they were faxed to referring physicians.
Sold states
US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
Affected count
9 sites potentially have the affected version
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
DR Systems Unity PACS software, now known as Merge Unity PACS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1426-2017Don't want to check this manually?
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