FDA-Device2017-03-08Class II
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Merge Healthcare, Inc.
Hazard
The software is not adding the correct tomo image.
Sold states
US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
Affected count
28 sites potentially have the affected 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. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2017Don't want to check this manually?
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