Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2006-2026
• FDA 510(k) clearance · K190887The device's official FDA premarket clearance record
• FDA device classification · HAWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Elekta, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.