BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Leksell Vantage Arc System REF: 1053958

    Recall: Z-2006-2026 · Initiated March 19, 2026

    Recall

    Recall Number
    Z-2006-2026
    Event Number
    98612
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    HAW
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 19, 2026
    Posted
    April 29, 2026
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    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.

    Action

    On March 19, 2026 Elekta issued a "Urgent: Medical Device Recall" notification via e-mail. Elekta asked consignees 1. Before each operation, products should be cleaned, sterilized (unless specified otherwise), and checked for proper functionality. 2. Make sure to examine all scales and angles to make sure that they are correctly set and securely fixed before proceeding. 3. Make sure to obtain a second person in the OR room to read the coordinate settings so as to ensure they are correct and check they are securely locked. 4. Before you continue, check that all parts are assembled correctly, firmly attached, and locked in place. 5. Inspect the equipment for visible signs of damage before clinical use. Do not use damaged equipment for any purpose. If you suspect that any part is damaged, contact your Elekta representative immediately. 6. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. 7. Advise the appropriate personnel working with this product, on the content of this letter. If the product has been transferred to another facility, please provide them with a copy of this communication.

    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)