Company: Merge Healthcare, Inc.
Date of Enforcement Report 4/5/2017
Class lI:
PRODUCT
iConnect Enterprise Archive software
Recall Number Z-1700-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
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
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.
___________________________________
