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Merge Healthcare, Inc. recalls Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy readin
Recalled June 21, 2017 · FDA recall Z-2591-2017 · Merge Healthcare
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. · FDA Class II
Units
47 sites have the potentially affected versions
Sold at
Nationwide Distribution
Description
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.
Product
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
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →