FDA-Device2016-11-23Class II
Merge PACS software. Product Usage: 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
The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.
Sold states
Worldwide Distribution - US Nationwide including Canada.
Affected count
534 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge PACS software. Product Usage: 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-0599-2017Don't want to check this manually?
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