Recall – PACS software causes prior thumbnails to not display correctly

Company: Merge Healthcare, Inc.
Date of Enforcement Report: 7/31/2019
Class II


Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Recall Number: Z-2062-2019


Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).


Merge Healthcare, Inc. on 7/11/2019. Voluntary:  Firm Initiated recall is ongoing.

179 devices


Nationwide and Worldwide

Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here:


Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here:–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610


Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.