Recall Z-1498-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1498-2017
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 2020-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.. Reason: System locks up which may result in potential patient injury or delay in diagnosis or treatment..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2020-06-15
Firm location: Hartland, WI, United States

Product description

Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.

Reason for recall

System locks up which may result in potential patient injury or delay in diagnosis or treatment.

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