RESOUNDANT ACOUSTIC DRIVER SYSTEM (MR ELASTOGRAPHY SYSTEM)

Additional Manufacturer Narrative

NO DEATH OR SERIOUS INJURY HAS BEEN REPORTED. CLINICAL ASSESSMENT HAS DETERMINED THAT THE ISSUE COULD POTENTIALLY DELAY TREATMENT OR FOLLOW-UP CARE. (PER SEC. 7) FSN PROVIDED TO MR SCANNER MANUFACTURER. DATES: INITIAL COMPLAINT RECEIVED 12DEC2025. PHYSICIAN'S PERSPECTIVE ON INACCURATE STIFFNESS ESTIMATES RECEIVED ON (B)(6) 2026 ('BECOME AWARE' DATE REGARDING REPORTABILITY).

Description of Event or Problem

IT HAS COME TO OUR ATTENTION THAT (WHEN USED WITH OUR SYSTEM) THE DEFAULT MRE ACQUISITION PARAMETERS INSTALLED ON CURRENT PHILIPS SCANNERS RESULT IN INCORRECT MEASUREMENTS OF LIVER STIFFNESS. THIS CAN EFFECT CLINICAL STAGING OF LIVER DISEASE AND IS THEREFORE A PATIENT SAFETY RISK. SPECIFICALLY, PIXEL SIZES IN DEFAULT PROTOCOLS ARE 1.25MM OR SMALLER BUT SHOULD BE NEAR 1.65MM FOR ACCURATE STIFFNESS ESTIMATES. THIS ISSUE AFFECTS ALL PHILIPS USERS OF R5.X, R11, AND R12 SOFTWARE (ALL OF WHICH HAVE MMDI 3.0.4 AS PART OF MRE VIEW) AND THAT SCAN THE DEFAULT PHILIPS PROTOCOL FOR MRE. NEITHER RESOUNDANT NOR PHILIPS HARDWARE ARE IMPLICATED HERE, THE ISSUE IS CONTAINED TO PROTOCOL SETTINGS.