FDA-Device2017-06-21Class II
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Merge Healthcare, Inc.
Hazard
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Sold states
Nationwide Distribution
Affected count
47 sites have the potentially affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2017Don't want to check this manually?
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