Brand Name: Leksell Vantage Arc System REF: 1053958

FDA device recall Z-2006-2026 · posted 2026-04-29 · Open, Classified

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

HAW

Quantity affected

768 (364Left/364Right)

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 E

Date initiated

2026-03-19

Date posted

2026-04-29

Location

Atlanta, GA

Related 510(k) clearances