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FDA-Device2026-03-25Class IIPROCESSING DEFECT

Elekta Leksell Gamma Knife Perfexion and Icon recalled for misaligned adapter

Elekta
OTHERNationwide distribution

Check your Leksell Gamma Knife serial number

Elekta has recalled certain Leksell Gamma Knife Perfexion and Icon radiosurgery systems because an adapter component may not be properly aligned or locked in place. This could affect the accuracy of radiation delivery during treatment. No injuries have been reported.

  • Check if your system's serial number matches the affected list
  • Contact Elekta immediately if your system is listed
  • Do not use the system until Elekta provides further guidance
  • Follow any instructions from Elekta regarding inspection or replacement
Hazard

Due to adapter not being properly aligned or locked in place.

Sold states
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 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.
Affected count
352
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1581-2026

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