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Merge Healthcare, Inc. recalls Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed f
Recalled November 23, 2016 · FDA recall Z-0599-2017 · Merge Healthcare
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. · FDA Class II
Units
534 sites potentially have the affected versions
Sold at
Worldwide Distribution - US Nationwide including Canada.
Description
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.
Product
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.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →