BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOUNDANT ACOUSTIC DRIVER SYSTEM (MR ELASTOGRAPHY SYSTEM)

    MDR report key: 24406128 · Received February 20, 2026

    Report

    Report Number
    3013695852-2026-00001
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    December 12, 2025
    Report Date
    February 20, 2026
    Manufacturer
    RESOUNDANT INC.
    Product Code
    LNH
    PMA / PMN Number
    K201389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461524 RESOUNDANT ACOUSTIC DRIVER SYSTEM (MR ELASTOGRAPHY SYSTEM) MR ELASTOGRAPHY LNH RESOUNDANT INC. RESYS3002(4001)-RESYSAB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other