Leksell Gamma Knife Perfexion and Icon models recalled due to adapter misalignment
Elekta recalls Leksell Gamma Knife Perfexion and Icon models with adapter not properly aligned or locked, posing a risk of improper function during radiosurgery procedures.
Use caution until it’s fixed
Due to adapter not being properly aligned or locked in place.
Contact the company
What happened, in plain English
Elekta is recalling Leksell Gamma Knife Perfexion and Icon models because the adapter may not be properly aligned or locked in place. This could lead to improper function during radiosurgery procedures if the device is used without the adapter being correctly secured. Read more at govinfonow.com/recall/49958-leksell-gamma-knife-perfexion-and-icon-models-recalled-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/49958-leksell-gamma-knife-perfexion-and-icon-models-recalled-due-to · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1581-2026
Cite this page
“Leksell Gamma Knife Perfexion and Icon models recalled due to adapter misalignment.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49958-leksell-gamma-knife-perfexion-and-icon-models-recalled-due-to. Based on FDA recall #Z-1581-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1581-2026%22&limit=1).
Why it’s dangerous
The adapter in the device may not be properly aligned or locked in place, which could lead to improper function during radiosurgery procedures. This might result in incorrect radiation delivery to the target site.
Who’s affected
Medical professionals who own or use Leksell Gamma Knife Perfexion or Icon models for radiosurgery procedures are most at risk. Patients undergoing treatment with these devices may also be affected if the device malfunctions.
How to tell if you have this one
Check for product and serial numbers listed in the recall notice, which include specific model names (Perfexion, Icon, and Esprit) and unique identifiers like LGK Perfexion/11868-004/6002 or LGK Icon/30004749-LGK001/8099.
- Brand
Leksell Gamma Knife- Category
Medical device
What to do — step by step
Check Device Model
Identify your device model by checking the product and serial numbers listed in the recall notice, such as LGK Perfexion/11868-004/6002 or LGK Icon/30004749-LGK001/8099.
Contact Manufacturer
Contact Elekta directly to confirm if your device is affected and to receive instructions on next steps.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 36 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 35 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-1581-2026 (February 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1581-2026 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.