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Merge Healthcare, Inc. recalls iConnect Enterprise Archive software.
Recalled April 5, 2017 · FDA recall Z-1700-2017 · Merge Healthcare
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. · FDA Class II
Units
371 sites potentially have the affected software
Sold at
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.
Description
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.
Product
iConnect Enterprise Archive software.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →