FDA recall, , Moderate risk
Leksell Gamma Knife
The Leksell Gamma Knife has an adapter that may not be properly aligned or locked in place.
Summary by Recall Canary from the FDA notice
What happened
Elekta, Inc., of Atlanta, Georgia, recalled the Leksell Gamma Knife radiosurgery system, including the Elekta Esprit, Icon, and Perfexion models, because the adapter may not be properly aligned or locked in place. The recall began on February 18, 2026, and was added to the FDA's Enforcement Report on March 19, 2026, with distribution worldwide, including nationwide in the United States.
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.
Leksell Gamma Knife
- UDI-DI
- 07340048303019
- 30002718
- 30002934
- 30000655
- 30001910
- 30000732
- 30001270
- 30001527
- 30000722
- 30001107
- 30003042
- 30000346
- 30004796
- 30000269
- 30002079
- 07340048305587
- 30004749
- 30004694
- 30000718
- 30004889
- 30005412
- 30004236
- 30002968
- 30000736
- 30005910
- 30004024
- 30006128
- 30004887
- 30006248
- 30000656
- 30000333
- 30001254
- 30005199
- 30001255
- 30001751
- 30004975
- 30003654
- 30004895
- 30000767
- 30002955
- 30007880
- 30007230
- 30002346
- 30000118
- 07340201501139
- 30008463
- 30004455
- 30006645
- 30002563
- 30006828
- 30002306
- 30006511
- 30008296
- 30005168
- 30002888
- 30001913
- 30003406
- 30000171
- 30006566
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, PR, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. The countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
- 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
- 98443
- Recall number
- Z-1581-2026
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
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
