Elekta, Inc. — 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.
Is this relevant to me?
- Geography
- 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
- Source agency
- FDA
- Category
- Health
- Published
- March 19, 2026
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
What's affected?
- Product
- Brand Name: Leksell Vantage Arc System REF: 1053958
- Brand
- Elekta, Inc.
- Lot code
- Arc
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 768 (364Left/364Right).
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