BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX X-RAY PORTABLE

    MDR report key: 23479272 · Received November 5, 2025

    Report

    Report Number
    MW5178548
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 29, 2025
    Report Date
    October 31, 2025
    Manufacturer
    CARESTREAM HEALTH, INC
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS EVENT INVOLVES A CARESTREAM X-RAY PORTABLE UNIT. WE HAD AN INCIDENT THIS MORNING WHEN THE X-RAY TUBE HOUSING FELL OFF THE ARM. THE PHOTOS ARE OF THE ROTATIONAL BRAKE AND YOKE ASSEMBLY. THE SHAFT BROKE AT THE WELD ON THE TUBE ASSEMBLY. I DO NOT UNDERSTAND HOW THE VENDOR WOULD WELD THE SHAFT IN LIEU OF A SOLID SHAFT IS BEYOND ME. WE WERE VERY FORTUNATE THAT THIS DID NOT OCCUR WHILE OVER THE PATIENT OR SIGNIFICANT INJURY WOULD HAVE OCCURRED. THE CARESTREAM FSR IS ON THEIR WAY TO EVALUATE. I HAVE NO CHOICE BUT TO TAKE THE OTHER CARESTREAM PORTABLE OUT OF SERVICE. I AM CONCERNED FOR THE OTHER FACILITIES WITH THE SAME SYSTEM. ALSO ATTACHED IS THE MODEL AND SERIAL NUMBER DETAILS FOR THIS PORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280892 DRX X-RAY PORTABLE SYSTEM, X-RAY, MOBILE IZL CARESTREAM HEALTH, INC DRXR-1 CGF-32-M0185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other