BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLUTION

    MDR report key: 24931927 · Received April 20, 2026

    Report

    Report Number
    9613445-2026-00004
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 22, 2026
    Report Date
    April 20, 2026
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    UDI-DI
    00195278940292
    PMA / PMN Number
    K192686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS BEIJING - WEST AREA OF BUILDING NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT AREA CHINA BEIJING, BEIJING, 100176. BLOCK A: FE INFORMATION WAS NOT OBTAINED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING INSTALLATION OF THE SYSTEM, A FIELD ENGINEER'S FINGER GOT PINCHED IN THE DOLLY HE WAS USING TO REMOVE THE FRONT COVER OF THE GANTRY. THE REPORTED INJURY WAS TREATED WITH TWO STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993713 REVOLUTION COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE HANGWEI MEDICAL SYSTEMS CO., LTD. MAXIMA QU 00195278940292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention