FDA Medical devices recall ·
Leksell Vantage Arc System recall
- Recall number
- Z-2006-2026
- Date
- (initiated March 19, 2026)
- Company / brand
- Elekta, Inc.
400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 768 (364Left/364Right)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Leksell Vantage Arc System REF: 1053958
Why was it recalled?
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
States: Arkansas Arizona California District of Columbia Florida Georgia Illinois Kansas Maryland Missouri Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York South Carolina Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2006-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.