FDA recall, , Moderate risk
Leksell Vantage Arc System
The Leksell Vantage Arc System has locking mechanisms that may not secure properly, causing coordinate shifting.
Summary by Recall Canary from the FDA notice
What happened
Elekta, Inc., of Atlanta, Georgia, recalled the Leksell Vantage Arc System, REF 1053958, because locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. The company began the recall on March 19, 2026, and the FDA added it to its Enforcement Report on April 29, 2026.
The recalled system was distributed in the US across 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 and OUS in 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.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Brand Name: Leksell Vantage Arc System REF: 1053958
- UDI-DI
- 07340048304856
- 07340048304818
- 07340048304801
Recall details
- Company began the recall
- Sold in
- 31 states and DC
US: Arkansas Arizona California Colorado District of Columbia Florida Georgia ID Illinois Kansas Massachusetts MD ME Missouri Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio OK Pennsylvania South Carolina Texas Utah Virginia Washington Wisconsin West Virginia 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
- Company
- Elekta, Inc.Atlanta, Georgia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98612
- Recall number
- Z-2006-2026
- Quantity recalled
- 768 (364Left/364Right)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
