Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leks

Recalling company

Elekta, Inc.

Product

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.

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 18, 2026

Reported

Mar 25, 2026

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 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.

Status

Ongoing

Quantity

352

Lot / codes

Lot Code: 07340048303019 (Perfexion) Product and Serial Numbers: LGK Perfexion/11868-004/6002 LGK Perfexion/12214-003/6007 LGK Perfexion/10567-026/6011 LGK Perfexion/10567-024/6014 LGK Perfexion/12451-001/6019 LGK Perfexion/10064-008/6021 LGK Perfexion/18630-001/6031 LGK Perfexion/11813-003/6034 LGK Perfexion/11007-005/6035 LGK Perfexion/10908-003/6045 LGK Perfexion/13337-LGK001/6052 LGK Perfexion/10762-005/6057 LGK Perfexion/11550-001/6065 LGK Perfexion/14878-003/6067 LGK Perfexion/11792-005/6077 LGK Perfexion/10356-007/6079 LGK Perfexion/10924-001/6089 LGK Perfexion/15045-LGK001/6091 LGK Perfexion/11848-003/6095 LGK Perfexion/12236-006/6097 LGK Perfexion/13558-001/6099 LGK Perfexion/20364-001/6103 LGK Perfexion/10848-LGK001/6108 LGK Perfexion/11390-LGK001/6109 LGK Perfexion/30002718-001/6113 LGK Perfexion/11433-LGK001/6116 LGK Perfexion/10643-005/6117 LGK Perfexion/11990-LGK001/6118 LGK Perfexion/12620-002/6120 LGK Perfexion/17322-001/6121 LGK Perfexion/105528-001/6122 LGK Perfexion/11999-001/6126 LGK Perfexion/10917-004/6128 LGK Perfexion/17357-001/6130 LGK Perfexion/10394-LGK01/6144 LGK Perfexion/30002934-ENS/6160 LGK Perfexion/10583-LGK002/6161 LGK Perfexion/16867-001/6166 LGK Perfexion/10929-LGK002/6175 LGK Perfexion/10424-001/6182 LGK Perfexion/17539-001/6185 LGK Perfexion/11377-003/6186 LGK Perfexion/16647-001/6187 LGK Perfexion/11733-001/6192 LGK Perfexion/10960-005/6193 LGK Perfexion/21061-001/6195 LGK Perfexion/11439-002/6196 LGK Perfexion/30000655-001/6199 LGK Per

Company location

Atlanta, GA

Recall type

Voluntary: Firm initiated

Recall number

Z-1581-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1581-2026 in the FDA Enforcement Report. Also see FDA recall press releases.