Company: Merge Healthcare, Inc.
Date of Enforcement Report 4/5/2017
iConnect Enterprise Archive software
Recall Number Z-1700-2017
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.
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
371 sites potentially have the affected accessory
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.