BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No

    Recall: Z-1164-2026 · Initiated December 14, 2025

    Recall

    Recall Number
    Z-1164-2026
    Event Number
    97958
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 14, 2025
    Posted
    January 23, 2026
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No

    Reason

    Due to a manufacturing issue and electrical grounding of systems.

    Action

    On 12/14/2025, the firm emailed an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" Letter to customer informing them that Elekta has identified a safety issue relating to the modulator discharge rod, where the supplier has been fitting the crimp in the crimp tool back to front. The issue was discovered during production. Note - The discharge rod is used by Field Service Engineers (FSE) when completing service activities on the machine around the HT and RF (High Tension (high voltage) and Radio Frequency) assembly. Instructions to customer: No actions are required to be taken by the Clinical user. Instructions for Field Service Engineers: Possible impact on the Field Service Engineer:- The FSE uses the HT discharge rod to fully discharge the voltage capacitor. Once the FSE has completed the procedure using the discharge rod, the FSE will start to work on the system around the HT and RF assembly. If the discharge rod is not fully connected to the ground or not connected at all, the system will still be fully charged and the FSE could receive an electric shock. Elekta will release an Important Field Safety Modification (IFSM) to identify potentially faulty discharge rod crimping and provide further instructions. The IFSM will include procedures for verifying the reliability of the discharge rod crimping and replacing affected components if necessary. local Elekta service representative will contact you to arrange for this activity to be completed.

    Distribution

    Worldwide

    Quantity

    5391