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 TECHNICAL SUPPORT RECEIVED A COMPLAINT FROM A SITE'S RADIOLOGY IT/PACS ADMINISTRATOR REPORTING THAT, WHEN LAUNCHING A STUDY IN MERGE PACS, IMAGES FROM TWO DIFFERENT PATIENTS WERE DISPLAYED TOGETHER. THE COMPLAINT WAS INITIALLY INVESTIGATED AND THE REPORTED BEHAVIOR COULD NOT BE REPRODUCED. ON (B)(6) 2026, A SECOND COMPLAINT DESCRIBING SIMILAR BEHAVIOR WAS RECEIVED. SUBSEQUENT INVESTIGATION CONFIRMED THAT, UNDER CERTAIN CONDITIONS, THE SOFTWARE COULD DISPLAY IMAGES ASSOCIATED WITH DIFFERENT PATIENTS WITHIN THE SAME VIEWING SESSION. THE ISSUE WAS DETERMINED TO BE A SOFTWARE MALFUNCTION. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED.