Recall Z-1700-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1700-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-04-04, terminated 2020-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: iConnect Enterprise Archive software.. 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: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2020-10-05
Firm location: Hartland, WI, United States

Product description

iConnect Enterprise Archive software.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.