MERGE PACS

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE IS DUE TO A SOFTWARE DEFECT INTRODUCED IN MERGE PACS 9.4. ALTHOUGH THERE ARE SEVERAL VISUAL CUES TO ALERT USERS TO THE PRESENCE OF NEW IMAGES WHEN VIEWING A STUDY, UNDER HIGH-VOLUME CLINICAL WORKLOADS THERE IS A POTENTIAL RISK THAT RADIOLOGISTS MAY READ AND INTERPRET IMAGES FOR THE INCORRECT PATIENT IN THE CURRENT STUDY CONTEXT. AN IMMEDIATE WORKAROUND IS BEING DEPLOYED TO AFFECTED CUSTOMERS TO DISABLE THE FEATURE THROUGH A CONFIGURATION CHANGE, AND A SOFTWARE UPDATE IS UNDER DEVELOPMENT TO ELIMINATE THE ROOT CAUSE IN ALL AFFECTED VERSIONS.

Description of Event or Problem

ON (B)(6) 2026, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A CUSTOMER. THE SITE'S PACS ADMINISTRATOR REPORTED THAT THUMBNAIL IMAGES FROM A PREVIOUS PATIENT'S STROKE PROTOCOL WERE DISPLAYED IN THE THUMBNAIL BAR FOR A SUBSEQUENT PATIENT. NO INJURY WAS REPORTED. IF THE ISSUE WERE TO RECUR, IT COULD POTENTIALLY LEAD TO INCORRECT CLINICAL INTERPRETATION.