SYNAPSE PACS

Description of Event or Problem

ON 06/04/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A BUG IN SYNAPSE PACS V7.4.310 THAT COULD POTENTIALLY LEAD TO A MISDIAGNOSIS IN THE CARDIOLOGY BASED STUDIES. IT WAS FOUND DURING REGRESSION TESTING OF THE PRODUCT THAT THE ANNOTATION TAKEN AND SAVED IN AN EARLIER VERSION OF THE PRODUCT CAN SHOW THE INCORRECT VALUE IN BOTH ZERO VIEWER (ZV) AND VX WHEN REOPENING THE STUDY IN THE NEWER VERSION. THIS ISSUE WAS INTRODUCED INTO THE PRODUCT DURING AN ENHANCEMENT TO SUPPORT MEASUREMENT OF OVERLAPPING ULTRASOUND (US) REGION DATA TYPES, TO MAKE MEASUREMENTS ON US IMAGES THAT CONTAIN OVERLAPPING REGIONS SO THAT A USER CAN ACCURATELY CHARACTERIZE ANATOMY DURING REPORTING. THE INCORRECT MEASUREMENT IS NOT DETECTABLE BY THE USERS. CONSEQUENTLY, THE TREATMENT PLAN COULD BE IMPACTED BY HAVING THE PATIENT ASSESSED BY UNNECESSARY ADDITIONAL TESTING OR OMITTING NECESSARY TESTING. ALTHOUGH NO PATIENT HAS BEEN AFFECTED BY THE PRODUCT PROBLEM TO THIS DATE, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4).

Additional Manufacturer Narrative

FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4). FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A BUG IN SYNAPSE PACS V7.4.310 THAT COULD POTENTIALLY LEAD TO A MISDIAGNOSIS IN THE CARDIOLOGY BASED STUDIES. HERE IS THE INITIAL INVESTIGATION. THIS ISSUE WAS INTRODUCED INTO THE PRODUCT DURING AN ENHANCEMENT TO SUPPORT MEASUREMENT OF OVERLAPPING ULTRA SOUND (US) REGION DATA TYPES, TO MAKE MEASUREMENTS ON US IMAGES THAT CONTAIN OVERLAPPING REGIONS SO THAT A USER CAN ACCURATELY CHARACTERIZE ANATOMY DURING REPORTING. MEASUREMENTS THAT CAN BE TAKEN ON A US: A. RULER. B. ANGLE. C. FREEHAND ROI. D. VELOCITY. E. VTI. F. AREA. G. VOLUME. H. SLOPE. I. ELLIPSE. FROM THIS LIST OF MEASUREMENTS, ONLY THE RULER MEASUREMENT WAS FOUND TO BE IMPACTED BY THIS ISSUE. WHEN TESTING RULER MEASUREMENTS ON A NON SQUARE MMODE IMAGE, THE MEASUREMENT APPEARED DIFFERENT THAN IN PREVIOUS VERSIONS. THE DIFFERENCE WILL BE VARIABLE, DEPENDING UPON THE STUDY AND IF THE STUDY INCLUDES THE PIXEL ASPECT RATIO WITH DATA. THE PIXEL ASPECT RATIO DEFINES THE RATIO OF VERTICAL TO HORIZONTAL PIXEL DIMENSIONS AND IS REPRESENTED AS A PAIR OF INTEGERS SPECIFYING VERTICAL AND HORIZONTAL PIXEL SIZES. IT ENSURES THAT IMAGES WITH NON-SQUARE PIXELS ARE DISPLAYED AND MEASURED CORRECTLY. IT IS A SIMPLE INTEGER RATIO OF VERTICAL TO HORIZONTAL PIXEL DIMENSIONS, REQUIRED WHEN OTHER SPACING ATTRIBUTES ARE MISSING, AND IS ESSENTIAL FOR ACCURATE IMAGE SCALING AND INTERPRETATION IN MEDICAL IMAGING WORKFLOWS. MISDIAGNOSIS COULD LEAD TO IMPROPER TREATMENT OF THE PATIENT. THE TREATMENT PLAN COULD BE IMPACTED BY HAVING THE PATIENT ASSESSED BY FURTHER TESTING OR FURTHER TESTING MAY NOT BE REQUESTED DUE TO THE VALUE IN THE MEASUREMENT.