FDA-Device2017-04-05Class II
iConnect Enterprise Archive software.
Merge Healthcare, Inc.
Hazard
The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.
Sold states
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.
Affected count
371 sites potentially have the affected software
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
iConnect Enterprise Archive software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1700-2017Don't want to check this manually?
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