Merge Healthcare, Inc.: System, Image Processing, Radiological

Recall Summary Merge Healthcare is recalling its OrthoPACS medical imaging diagnostic workstation because of a software issue where thumbnails from a previously viewed patient's images may incorrectly appear while a different patient's study is open. The issue affects the system's Thumbnail Bar display and has been distributed worldwide, including throughout the United States, Canada, and the UK. This is classified as a Class II recall.

Recalling firm
Merge Healthcare, Inc.
Product
Merge OrthoPACS, medical imaging diagnostic workstation
Reason
Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-06-30
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, and UK.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/7951deb4-41ab-4218-a25b-a3dec9c617d6