Merge PACS software Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/17/2016
Class lI:


Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Recall Number Z-2379-2016

The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.

Merge Healthcare, Inc, Hartland, WI on 1/20/2016. Voluntary: Firm Initiated recall is ongoing.

93 sites have the affected version

The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution


About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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