Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958
- Recalling company
- Elekta, Inc.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 19, 2026
- Reported
- May 6, 2026
- 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
- Status
- Ongoing
- Quantity
- 768 (364Left/364Right)
- Lot / codes
- 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
- Company location
- Atlanta, GA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2006-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2006-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.