BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FDR VISIONARY SUITE B40 UL 80KW GENERATOR SA42

    MDR report key: 23818057 · Received December 16, 2025

    Report

    Report Number
    1000513161-2025-00033
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    December 4, 2025
    Report Date
    February 19, 2026
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    KPR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER AGREEMENT WITH CUSTOMER, THE CUSTOMER IS RESPONSIBLE TO DESIGN AND IMPLEMENT AN ASSEMBLY THAT MEETS THE SYSTEM'S REQUIREMENTS FOR THE SPECIFIC ROOM WHERE THE EQUIPMENT WILL BE DEPLOYED. CUSTOMER PROVIDED A TIMELINE OF DEMOLITION OF ROOM AND STRUCTURAL REPAIR AS PART OF THE INSTALL OF THE NEW EQUIPMENT. EXPECTED COMPLETION OF CONSTRUCTION IS END OF FEBRUARY 2026 WITH INSTALLATION TO FOLLOW. INITIAL IMPORTER MDR 1000513161-2025-00033 WAS SUBMITTED DUE TO SAFETY OF THE PATIENT. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT #(B)(4) (FOR PATIENT).

    Description of Event or Problem · 0

    ON 12/04/2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING THE FDR VISIONARY SUITE B40 UL 80KW GENERATOR SA42. IT WAS REPORTED THAT THE OTCX FELL DOWN FROM THE CEILING IN VISIONARY SUITE ROOM 1 AT THE FACILITY. IT BROKE FROM THE CEILING AND COLLAPSED, AT LEAST IN PART, ON THE PATIENT WHO WAS BEING IMAGED. THE PATIENT WAS BEING IMAGED FOR A T-SPINE AND C-SPINE. AFTER THE OTCX FELL FROM THE CEILING, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM DEPARTMENT OF THE HOSPITAL, WHERE SHE THEN HAD TO COMPLETE A CAT SCAN OF THE HEAD AND AN X-RAY OF THE SHOULDER. THE PATIENT WAS EMOTIONALLY TRAUMATIZED AND CRIED BECAUSE SHE HAD TO UNDERGO ADDITIONAL SCANNING. THE ROOM HAS BEEN SHUT DOWN, AND NO PATIENTS ARE BEING SCANNED AT THIS TIME. DUE TO SAFETY OF THE PATIENT, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS REPORTING THIS EVENT. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4) (FOR PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875146 FDR VISIONARY SUITE B40 UL 80KW GENERATOR SA42 SYSTEM, X-RAY, STATIONARY KPR SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDR VISIONARY SUITE B40 UL 80KW GENERATOR SA42 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Hospitalization