BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Leksell Vantage Arc System REF: 1053958

    Recall: Z-2006-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2006-2026
    Event ID
    98612
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2026
    Initiation Date
    March 19, 2026
    Classification Date
    April 29, 2026
    Address
    400 Perimeter Center Ter NE Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    Brand Name: Leksell Vantage Arc System REF: 1053958

    Reason

    Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

    Code Info

    Lot Code: Arc System: UDI:07340048304856 Parts of Arc System: Left Z-Slide: Serial Numbers :UDI: 07340048304818 00001 00625 Right Z-Slide: UDI: 07340048304801/ Serial Numbers: 00001 00675

    Distribution

    US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA SC TX UT VA WA WI WV OUS: Algeria Australia Austria Azerbaijan Belgium China Colombia Costa Rica Croatia Czech Republic Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea, Republic of Kuwait Lithuania Mexico Morocco Netherlands New Zealand Norway Pakistan Panama Poland Portugal Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Kingdom

    Quantity

    768 (364Left/364Right)