Recall Z-2620-2017— Merge Healthcare, Inc.

Name: FDA recall Z-2620-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-24

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2017-05-24, terminated 2019-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Merge OrthoPACS software.. Reason: A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-24
Terminated: 2019-06-28
Firm location: Hartland, WI, United States

Product description

Merge OrthoPACS software.

Reason for recall

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

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