BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMX

    MDR report key: 25080887 · Received May 5, 2026

    Report

    Report Number
    9616047-2026-00001
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 5, 2026
    Manufacturer
    GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.
    Product Code
    IZL
    UDI-DI
    00195278003348
    PMA / PMN Number
    K210982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE¿S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. LEGAL MANUFACTURER: GE MEDICAL SYSTEMS, LLC - 3000 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.

    Description of Event or Problem · 0

    ON 06-APR-2026, A GE HEALTHCARE FIELD ENGINEER (FE) WAS ONSITE AT (B)(6) HOSPITAL (USA) PERFORMING SERVICE ON AN AMX NAVIGATE MOBILE X-RAY SYSTEM. DURING THE SERVICE ACTIVITY, THE FE OBSERVED THAT A FASTENER WAS MISSING FROM THE X-RAY TUBE COVER. THE MISSING FASTENER WAS CONFIRMED TO BE THE SAME COMPONENT ASSOCIATED WITH A PREVIOUSLY IDENTIFIED SENTINEL EVENT. NO PATIENT OR USER INJURY WAS REPORTED AT THE TIME OF DISCOVERY. BASED ON THE KNOWN ASSOCIATION WITH A PRIOR SENTINEL EVENT, THIS OCCURRENCE REPRESENTS A REPORTABLE MALFUNCTION, AS RECURRENCE OF THIS MALFUNCTION COULD POTENTIALLY LEAD TO A SERIOUS INJURY IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79971 AMX SYSTEM, X-RAY, MOBILE IZL GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V. NAVIGATE 00195278003348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown