BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORT200 TABLE

    MDR report key: 23383734 · Received October 24, 2025

    Report

    Report Number
    3010326005-2025-00003
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 24, 2025
    Manufacturer
    IMRIS IMAGING, INC.
    Product Code
    KXJ
    UDI-DI
    00857534006349
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMRIS FIELD SERVICE ENGINEER ISOLATED THE CAUSE TO AN ACTUATOR COMPONENT WITHIN THE TABLE'S ROTATIONAL LOCKING MECHANISM. THE FIELD ENGINEER ROTATED THE TABLE AND RE-ENGAGED THE LOCKING MECHANISM, WHICH SUCCESSFULLY LOCKED THE TABLE POSITION. END USER WAS INFORMED OF THE FINDING AND THE ACTUATOR COMPONENT IS IN PROCESS OF BEING REPLACED. AN INTERNAL CORRECTIVE ACTION HAS BEEN INITIATED BY THE MANUFACTURER TO FURTHER ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    DURING THE ONE(1) YEAR PREVENTATIVE MAINTENANCE (PM), THE MANUFACTURER'S FIELD SERVICE ENGINEER REPORTED THE ROTATIONAL LOCK ON THE ORT200 OPERATING ROOM TABLE WAS STRUGGLING TO OBTAIN THE LOCK STATUS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790115 ORT200 TABLE OPERATING ROOM TABLE KXJ IMRIS IMAGING, INC. ORT200 00857534006349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other