BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported February 4, 2026

    Enforcement

    Recall Number
    Z-1164-2026
    Event ID
    97958
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2026
    Initiation Date
    December 14, 2025
    Classification Date
    January 23, 2026
    Address
    400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, 30346-1227, United States

    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.

    Code Info

    Lot Code: 05060191071550 (NFB) Elekta Synergy 05060191071505 (FB) 05060191071543 (NFB) Elekta Infinity 05060191071512 (FB) 05060191071574 (NFB) Versa HD 05060191071529 (FB) 05060191071581 Harmony 05060191071604 Harmony Pro 07340201503461 Elekta Evo

    Distribution

    Worldwide

    Quantity

    5391