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Merge Healthcare, Inc. recalls Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Me
Recalled August 17, 2016 · FDA recall Z-2379-2016 · Merge Healthcare
Hazard
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. · FDA Class II
Units
93 sites have the affected version
Sold at
The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.
Description
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Product
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →