Elekta Leksell Vantage Arc System Recall: Risk of shifting coordinates during procedures
Elekta recalls Leksell Vantage Arc System devices with potential shifting coordinates during procedures. Affected units have specific serial numbers and lot codes. Contact Elekta for remedy details.
Use caution until it’s fixed
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Contact the company
What happened, in plain English
Elekta is recalling Leksell Vantage Arc System devices that may shift coordinates during procedures due to faulty locking mechanisms. This could lead to inaccurate treatment outcomes in medical procedures. Read more at govinfonow.com/recall/49677-elekta-leksell-vantage-arc-system-recall-risk-of-shifting-coordinates.
Source Summary by GovInfoNow · govinfonow.com/recall/49677-elekta-leksell-vantage-arc-system-recall-risk-of-shifting-coordinates · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2006-2026
Cite this page
“Elekta Leksell Vantage Arc System Recall: Risk of shifting coordinates during procedures.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49677-elekta-leksell-vantage-arc-system-recall-risk-of-shifting-coordinates. Based on FDA recall #Z-2006-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2006-2026%22&limit=1).
Why it’s dangerous
The locking mechanisms in the Arc system may not secure properly, causing shifts in coordinates during medical procedures. This could result in inaccurate radiation targeting and potentially affect treatment outcomes.
Who’s affected
Medical professionals using the Leksell Vantage Arc System for radiation therapy are most at risk. Patients receiving treatments with affected devices may experience inaccurate radiation delivery.
How to tell if you have this one
Check for the Leksell Vantage Arc System with serial numbers starting with UDI: 07340048304818 or 00001 00625 on the left Z-Slide and UDI: 07340048304801 or 00001 00675 on the right Z-Slide.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check Device Serial Numbers
Verify the serial numbers on the left and right Z-Slides as listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 31 states and D.C., and outside the U.S.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Kansas, Maine, Maryland, Massachusetts, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2006-2026 (March 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2006-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.