BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON

    MDR report key: 23832838 · Received December 17, 2025

    Report

    Report Number
    2020563-2025-00011
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 18, 2025
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    OWB
    PMA / PMN Number
    K182415
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 DURING A PATIENT EXAM, THE SYSTEM LOST COMMUNICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039533 CANON INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB CANON MEDICAL SYSTEMS CORPORATION INFX-8000F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other