FDA-Device2016-08-24Class II
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems 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 unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Sold states
US Distribution to states of: CA, PA, TX, and MT.
Affected count
9 sites potentially have the affected version
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems 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-2551-2016Don't want to check this manually?
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