BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX EVOLUTION PLUS SYSTEM

    MDR report key: 24218943 · Received January 30, 2026

    Report

    Report Number
    1317307-2026-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 29, 2026
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    KPR
    UDI-DI
    60889978624263
    PMA / PMN Number
    K091889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH INC. (CSH) HAS INVESTIGATED THIS ISSUE AND IT WAS DETERMINED THAT THIS WAS NOT A DEVICE MALFUNCTION; AND NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED. THE DETACHMENT RESULTED FROM IMPROPER SERVICE INSTALLATION, AS THE MOUNTING WEDGE BLOCKS HAD NOT BEEN FULLY SECURED DURING SERVICING PERFORMED 1-2 DAYS EARLIER. THE COLLIMATOR WAS RESECURED, AND THE SERVICE TEAM WAS REMINDED OF THE CORRECT INSTALLATION PROCEDURE. NO PATIENT OR STAFF INJURIES OCCURRED. ALTHOUGH THE DETACHMENT RESULTED FROM A SERVICE INSTALLATION ERROR, IT OCCURRED DURING CLINICAL USE, MEANING THAT RECURRENCE UNDER SIMILAR CONDITIONS COULD LIKELY CAUSE SERIOUS INJURY. THEREFORE, THE EVENT IS BEING REPORTED TO THE FDA. THE RISK HAS BEEN MITIGATED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE REQUIRED, AND CARESTREAM HEALTH HAS CLOSED THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2026, CARESTREAM HEALTH INC. (CSH) WAS INFORMED OF AN INCIDENT WHILE USING THE CARESTREAM DRX-EVOLUTION PLUS SYSTEM. THE COLLIMATOR DETACHED FROM THE TUBE MOUNT AFTER AN X-RAY EXAM REMAINING SUSPENDED SOLELY BY ITS CABLE. NO PATIENT OR STAFF INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286723 CARESTREAM DRX EVOLUTION PLUS SYSTEM CARESTREAM DRX EVOLUTION PLUS SYSTEM KPR CARESTREAM HEALTH INC. 60889978624263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other