BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA UNITY

    MDR report key: 23037323 · Received September 12, 2025

    Report

    Report Number
    3015232217-2025-00058
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 13, 2025
    Report Date
    March 5, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    PMA / PMN Number
    K223209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G3 UPDATED.

    Additional Manufacturer Narrative · 0

    H11: THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    G1 BOX 2 UPDATED. G2 OTHER: UPDATED. G4: UPDATED. H11: UPDATED: THE CUSTOMER REPORTED HEARING ARCING SOUNDS. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. ON (B)(6) 2025, DURING A NORMAL SCAN OF A PATIENT, A CRACKLING NOISE WAS HEARD. A SCAN ABORT OCCURRED, TRIGGERED BY A RISK CONTROL MEASURE THAT ABORTS THE SCAN IF A CURRENT ERROR IS DETECTED IN THE GRADIENT AMPLIFIER. AN ERROR APPEARED ON THE MR COMPUTER SCREEN AND A "GRADIENT AMPLIFIER Y" ERROR WAS VISIBLE IN THE MRI LOG AT THE SAME TIME. NO PATIENT INJURY HAS BEEN REPORTED. THE MARLIN 1.5T IS AN INTEGRATED COMPONENT OF THE ELEKTA UNITY MR-LINAC SYSTEM. PHILIPS IS THE MANUFACTURER OF THE MARLIN 1.5T. ELEKTA IS THE LEGAL MANUFACTURER OF THE UNITY MR-LINAC SYSTEM AND HAS OVERALL RESPONSIBILITY FOR THE FINISHED MEDICAL DEVICE. THE ROOT CAUSE HAS BEEN IDENTIFIED BY PHILIPS. THE ROOT CAUSE WAS A FAILURE OF THE GRADIENT BUSBAR CONNECTION. THE WHOLE GRADIENT COIL HAS BEEN REPLACED. ELEKTA PERFORMED A RISK ASSESSMENT AND ASSESSED THE SEVERITY OF HARM TO BE "SERIOUS" AND PROBABILITY TO BE "IMPLAUSIBLE". THE RISK ASSESSMENT CONCLUDED THAT THE RISK IS CONSIDERED LOW. AN IMPORTANT SAFETY NOTICE (FCO) 200-01-801-012 WAS SUBMITTED TO ALL AFFECTED CUSTOMERS ON 04/04/2023. THIS WAS THEN SUPERSEDED ON 20/06/2023 WITH FCO 200-01-801-013 AND THEN ON 14/08/2025 THIS FCO WAS SUPERSEDED WITH FCO 200-01-801-016.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HEARING ARCING SOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588655 ELEKTA UNITY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown