Elekta Leksell Vantage Stereotactic System: Paint Flakes May Enter Wound
Elekta recalls Leksell Vantage Stereotactic System due to risk of paint flakes separating and entering surgical wounds during neurosurgery. Affected units have specific serial numbers.
Lower-risk recall
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
Contact the company
What happened, in plain English
Elek: The Leksell Vantage Stereotactic System software has a risk that paint flakes from engravings could separate and enter surgical wounds. This could cause complications during neurosurgery procedures. Read more at govinfonow.com/recall/51169-elekta-leksell-vantage-stereotactic-system-paint-flakes-may-enter-wound.
Source Summary by GovInfoNow · govinfonow.com/recall/51169-elekta-leksell-vantage-stereotactic-system-paint-flakes-may-enter-wound · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0433-2026
Cite this page
“Elekta Leksell Vantage Stereotactic System: Paint Flakes May Enter Wound.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51169-elekta-leksell-vantage-stereotactic-system-paint-flakes-may-enter-wound. Based on FDA recall #Z-0433-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0433-2026%22&limit=1).
Why it’s dangerous
Paint flakes from the device's engravings may separate and inadvertently enter the surgical wound during procedures. This could lead to complications or infections in the patient.
Who’s affected
Surgical teams using the Leksell Vantage Stereotactic System for neurosurgery procedures. Patients undergoing these procedures are at risk if the paint flakes enter the wound.
How to tell if you have this one
Check for serial numbers SH00001 to SH00338 on the Leksell Vantage Stereotactic System. The product was sold with specific lot codes and serial numbers as listed in the recall notice.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check Serial Numbers
Verify if your device has a serial number between SH00001 and SH00338.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 27 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, China,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Colorado, Florida, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 43 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.
Questions people ask
What should I do if I have this product?
Check your device's serial number to see if it falls within SH00001-SH00338. If it does, contact Elekta for further instructions.
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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-0433-2026 (September 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0433-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.