Brand Name: Leksell Vantage Arc System REF: 1053958 recall (Elekta, Inc.)
Medical deviceClass IIOngoing
Summary: Elekta, Inc. is recalling Brand Name: Leksell Vantage Arc System REF: 1053958. Reason: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
What is being recalled
Brand Name: Leksell Vantage Arc System REF: 1053958
Why
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 named: Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Maryland, Maine, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia)
How to tell if yours is affected
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 to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2006-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 19, 2026 |
| Reported | May 6, 2026 |
| Company | Elekta, Inc. |
| Company location | Atlanta, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 768 (364Left/364Right) |
More recalls from Elekta, Inc. · all medical device recalls · recalls from March 2026