FDAClass II · Medical device · Recalled May 6, 2026
Brand Name recall — Elekta, Inc.
Hazard: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2006-2026
- Brand
- Elekta
- Classification
- Class II
- Units affected
- 768 (364Left/364Right)
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Brand Name: Leksell Vantage Arc System REF: 1053958
Affected products
Companies & origin
- Recalling firm location
- Atlanta, GA, United States
- Firm address
- 400 Perimeter Center Ter NE Ste 50, 30346-1227
Identifying details (verbatim from the notice)
- Product codes / lots
- 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
- Firm notified the public via
- Letter
- FDA event ID
- 98612
- Recall initiated
- March 19, 2026
- FDA classified
- April 29, 2026
- FDA report date
- May 6, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 1:09 AM UTC.
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