FDA-Device2026-03-25Class II

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.

Elekta, Inc.

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

Official notice

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

Original summary

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. Due to adapter not being properly aligned or locked in place. 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 Perfexion/11731-005/6200 LGK Perfexion/11149-LGK002/6206 LGK Perfexion/11077-007/6207 LGK Perfexion/30001910-001/6208 LGK Perfexion/13514-001/6211 LGK Perfexion/10979-002/6213 LGK Perfexion/10208-003/6215 LGK Perfexion/11127-009/6219 LGK Perfexion/30000732-001/6223 LGK Perfexion/30001270-001/6225 LGK Perfexion/11420-001/6228 LGK Perfexion/30001527-001/6231 LGK Perfexion/10879-LGK002/6234 LGK Perfexion/10698-001/6237 LGK Perfexion/10711-002/6243 LGK Perfexion/10148-LGK002/6245 LGK Perfexion/12748-LGK001/6248 LGK Perfexion/11536-LGK002/6251 LGK Perfexion/10567-044/6253 LGK Perfexion/10425-LGK002/6254 LGK Perfexion/11434-LGK002/6255 LGK Perfexion/13031-LGK/6256 LGK Perfexion/11006-LGK002/6259 LGK Perfexion/30000722-003/6261 LGK Perfexion/10537-LGK002/6264 LGK Perfexion/30001107-002/6265 LGK Perfexion/10630-002/6266 LGK Perfexion/11524-002/8001 LGK Perfexion/12643-001/8010 LGK Perfexion/30003042-001/8011 LGK Perfexion/11695-LGK002/8015 LGK Perfexion/11322-002/8028 LGK Perfexion/10700-LGK002/8044 LGK Perfexion/12957-003/8053 LGK Perfexion/11787-003/8059 LGK Perfexion/30000346-001/8065 LGK Perfexion/30004796-RS001/8078 LGK Perfexion/11131-LGK002/8098 LGK Perfexion/13252-LGK001/8106 LGK Perfexion/30000269-LGK001/8109 LGK Perfexion/15490-003/8124 LGK Perfexion/30002079-LGK001/8180 07340048305587 (Icon) Product and Serial Numbers: LGK Icon/30004749-LGK001/8099 LGK Icon/14750-LGK001/8083 LGK Icon/12579-007/6250 LGK Icon/18850-500/8005 LGK Icon/11920-C5210/6088 LGK Icon/30004694-003/8064 LGK Icon/30000718-002/6246 LGK Icon/30004889-LGK001/8087 LGK Icon/14765-003/8027 LGK Icon/12473-003/6005 LGK Icon/12274-014/6209 LGK Icon/10611-001/6081 LGK Icon/11720-002/6143 LGK Icon/12846-004/6064 LGK Icon/12242-003/8085 LGK Icon/30005412-002/8114 LGK Icon/12178-002/8002 LGK Icon/12685-007/8105 LGK Icon/10545-009/8072 LGK Icon/12926-001/6212 LGK Icon/14915-003/6236 LGK Icon/30004236-003/8117 LGK Icon/30002968-004/8030 LGK Icon/12668-008/8178 LGK Icon/14983-500/6076 LGK Icon/11916-001/8056 LGK Icon/11083-HOM001/6070 LGK Icon/15554-001/8103 LGK Icon/15661-502/8121 LGK Icon/10247-002/6136 LGK Icon/30000736-003/8108 LGK Icon/30005910-001/8127 LGK Icon/11676-003/8040 LGK Icon/11976-502/8035 LGK Icon/11868-008/6131 LGK Icon/12947-003/8122 LGK Icon/11290-ENS1/6174 LGK Icon/18464-003/8066 LGK Icon/10795-K08002/6063 LGK Icon/30004024-RS01/6201 LGK Icon/11291-001/6018 LGK Icon/10326-003/6105 LGK Icon/21121-002/8067 LGK Icon/10783-003/8077 LGK Icon/30004796-RS001/8078 LGK Icon/30006128-500/8112 LGK Icon/30004887-LGK001/8069 LGK Icon/30006248-500/8125 LGK Icon/30000656-500/6227 LGK Icon/17414-004/8043 LGK Icon/17525-002/6038 LGK Icon/12629-003/6026 LGK Icon/15514-003/8034 LGK Icon/17522-001/6214 LGK Icon/20438-003/6013 LGK Icon/10416-LGK001/6125 LGK Icon/15748-LGK001/6106 LGK Icon/11019-LGK002/8071 LGK Icon/10997-LGK001/6087 LGK Icon/10832-LGK002/8115 LGK Icon/11992-LGK002/8029 LGK Icon/10654-LGK002/8100 LGK Icon/14900-LGK001/6058 LGK Icon/11230-LGK002/8025 LGK Icon/12958-L

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