Elekta, Inc.: Brand Name: Leksell Vantage Arc System REF: 1053958
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Elekta, Inc.
- Product
- Brand Name: Leksell Vantage Arc System REF: 1053958
- Reason / hazard
- Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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
- Recall initiated
- 2026-03-19
- Code info
- 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
- Product quantity
- 768 (364Left/364Right)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Atlanta
- State
- GA
- Country
- United States
- Event id
- 98612
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