FDAFDA · Food and drugs·Recall number Z-2006-2026
Brand Name: Leksell Vantage Arc System REF: 1053958
Published May 6, 2026 · Recall initiated: March 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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