FDA-Device2016-08-17Class II
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Hazard
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Sold states
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.
Affected count
93 sites have the affected version
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2379-2016Don't want to check this manually?
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