Home / Recalls / Elekta, Inc. / Z-1581-2026

Z-1581-2026 Class II Ongoing

Recalled by Elekta, Inc. — Atlanta, GA

FDA device recall Z-1581-2026 was initiated by Elekta, Inc. on February 18, 2026 and is designated Class II. Reason for recall: Due to adapter not being properly aligned or locked in place. The recall status is ongoing. Affected quantity: 352.

Recall Details

Product Type
Devices
Report Date
March 25, 2026
Initiation Date
February 18, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
352

Product Description

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 for Recall

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

Distribution Pattern

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.

Code Information

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-LGK002/8096 LGK Icon/11639-LGK001/6042 LGK Icon/13480-LGK003/8095 LGK Icon/11892-LGK002/8057 LGK Icon/11414-LGK002/6205 LGK Icon/11986-LGK003/8088 LGK Icon/11143-LGK002/6257 LGK Icon/11991-LGK003/8084 LGK Icon/10362-LGK002/8039 LGK Icon/10959-LGK001/6132 LGK Icon/11784-LGK001/6055 LGK Icon/10648-LGK001/6098 LGK Icon/10514-LGK002/6183 LGK Icon/30000333-LGK002/8119 LGK Icon/10103-LGK02/6149 LGK Icon/30001254-001/8092 LGK Icon/10104-LGK002/8046 LGK Icon/11530-001/6101 LGK Icon/19100-LGK001/8033 LGK Icon/10234-002/6111 LGK Icon/11586-001/6157 LGK Icon/15416-001/6086 LGK Icon/10444-LGK004/8003 LGK Icon/10728-001/6062 LGK Icon/11352-001/6044 LGK Icon/17033-LGK002/8113 LGK Icon/10974-503/8061 LGK Icon/40017-002/6170 LGK Icon/17260-LGK001/8073 LGK Icon/19046-LGK001/8036 LGK Icon/11674-LGK001/8031 LGK Icon/12109-002/6169 LGK Icon/12959-002/6033 LGK Icon/10420-AVL-GK/6156 LGK Icon/10590-LGK-01/8097 LGK Icon/10209-001/6046 LGK Icon/30005199-LGK001/8090 LGK Icon/30001255-LGK001/8091 LGK Icon/30001751-002/6068 LGK Icon/30004975-LGK001/8102 LGK Icon/105618-001/6110 LGK Icon/19633-001/6154 LGK Icon/30003654-LGK001/8054 LGK Icon/14958-504/6155 LGK Icon/30004895-001/8104 LGK Icon/30000767-LGK001/6104 LGK Icon/30002955-001/8016 LGK Icon/11553-001/6024 LGK Icon/11582-LGK001/8111 LGK Icon/17032-LGK002/8129 LGK Icon/11418-LGK002/8051 LGK Icon/10476-LGK001/6263 LGK Icon/30007880-LGKVDH/8131 LGK Icon/10118-001/6230 LGK Icon/30007230-LGK001/8133 LGK Icon/19710-LGK002/8070 LGK Icon/13271-LGK01/8076 LGK Icon/12270-001/8050 LGK Icon/10886-013/6027 LGK Icon/18062-001/6146 LGK Icon/13160-001/6039 LGK Icon/14117-005/8055 LGK Icon/11090-005/6165 LGK Icon/10434-004/6244 LGK Icon/11328-020/8063 LGK Icon/11395-010/6032 LGK Icon/10568-007/8094 LGK Icon/12752-004/6242 LGK Icon/10817-009/6204 LGK Icon/10591-002/6083 LGK Icon/10567-038/6107 LGK Icon/14569-001/6135 LGK Icon/13779-002/8026 LGK Icon/11054-004/8038 LGK Icon/15053-001/6179 LGK Icon/10039-004/8048 LGK Icon/10071-007/6119 LGK Icon/13120-011/8013 LGK Icon/11073-016/8080 LGK Icon/17674-003/8037 LGK Icon/30002346-001/8058 LGK Icon/10899-007/6260 LGK Icon/10597-002/6167 LGK Icon/10383-007/6100 LGK Icon/10383-009/8120 LGK Icon/10193-007/6056 LGK Icon/30000118-001/6240 LGK Icon/11039-006/6188 LGK Icon/10760-006/6173 LGK Icon/16717-002/8116 LGK Icon/10387-018/6093 LGK Icon/10894-003/8042 LGK Icon/11138-004/6115 LGK Icon/12269-002/6082 LGK Icon/11791-006/6022 LGK Icon/11834-004/6222 LGK Icon/10313-010/8136 LGK Icon/10909-024/8107 LGK Icon/10982-003/6053 LGK Icon/10176-002/8086 LGK Icon/11347-003/6134 LGK Icon/11256-001/6012 LGK Icon/12108-004/8041 LGK Icon/11360-004/6059 LGK Icon/10436-009/6150 LGK Icon/13553-005/6249 LGK Icon/11198-009/8081 LGK Icon/10673-022/8012 LGK Icon/14236-001/6114 LGK Icon/10492-003/8019 LGK Icon/19112-LGK001/8060 LGK Esprit UDI-DI code: 07340201501139 Product and Serial Numbers: LGK Esprit/10711-LGK001/8195 LGK Esprit/30008463-0002/8179 LGK Esprit/30004455-LGK001/8148 LGK Esprit/10587-LGK001/8181 LGK Esprit/12236-LGK013/8197 LGK Esprit/14874-005/8138 LGK Esprit/14857-003/8160 LGK Esprit/30006645-LGK001/8196 LGK Esprit/10684-002/6090 LGK Esprit/30002563-LGK001/8144 LGK Esprit/18649-004/8139 LGK Esprit/20116-001/8192 LGK Esprit/30006828-001/8167 LGK Esprit/11154-GK007/8151 LGK Esprit/30002306-LGK001/8164 LGK Esprit/11563-LGK003/8171 LGK Esprit/11670-LGK002/8166 LGK Esprit/10375-LGK002/8126 LGK Esprit/30006511-LGK001/8149 LGK Esprit/15104-LGK002/8147 LGK Esprit/30008296-LGK001/6223 LGK Esprit/19115-LGK001/8193 LGK Esprit/12028-LGK002/6217 LGK Esprit/10523-LGK001/8187 LGK Esprit/10459-LGK002/8152 LGK Esprit/10158-LGK/8163 LGK Esprit/40023-LGK002/8162 LGK Esprit/10444-001/8185 LGK Esprit/11352-LGK002/8154 LGK Esprit/17033-003/8183 LGK Esprit/11245-LGK001/8017 LGK Esprit/13125-NUC001/8158 LGK Esprit/12027-ETZ-G2/8134 LGK Esprit/12946-LGK001/8014 LGK Esprit/30005168-503/8172 LGK Esprit/10076-GK002/8045 LGK Esprit/11234-LGK001/8130 LGK Esprit/10779-08/8024 LGK Esprit/13370-006/8173 LGK Esprit/30002888-LGK001/6159 LGK Esprit/30001913-LGK001/8032 LGK Esprit/30003406-LGK002/8022 LGK Esprit/12766-LGK003/8123 LGK Esprit/10622-014/8140 LGK Esprit/11373-010/8145 LGK Esprit/11396-004/8176 LGK Esprit/10643-007/8191 LGK Esprit/11175-013/6229 LGK Esprit/30000171-003/6172 LGK Esprit/10349-007/8161 LGK Esprit/10636-007/8062 LGK Esprit/10567-053/6232 LGK Esprit/10567-050/8052 LGK Esprit/10567-048/8142 LGK Esprit/10567-054/8168 LGK Esprit/12164-005/8153 LGK Esprit/14030-004/8146 LGK Esprit/11714-005/8184 LGK Esprit/11092-004/8188 LGK Esprit/10255-013/8165 LGK Esprit/10877-012/8169 LGK Esprit/11740-003/8135 LGK Esprit/12864-LGK001/8186 LGK Esprit/10379-004/8137 LGK Esprit/13826-003/6239 LGK Esprit/10383-LGK012/6100 LGK Esprit/14153-003/8175 LGK Esprit/11798-014/8156 LGK Esprit/11888-007/6171 LGK Esprit/11710-006/8170 LGK Esprit/11077-009/8190 LGK Esprit/11030-011/8155 LGK Esprit/10542-015/6238 LGK Esprit/11201-006/6047 LGK Esprit/19485-002/8174 LGK Esprit/10909-013/8020 LGK Esprit/11293-008/8182 LGK Esprit/11226-004/8177 LGK Esprit/11820-008/8006 LGK Esprit/11772-007/8143 LGK Esprit/11198-008/8082 LGK Esprit/10673-031/8141 LGK Esprit/30006566-003/8118 LGK Esprit/11848-007/6095 LGK Esprit/10714-013/8159

Other recalls by Elekta, Inc.

  • Z-2406-2026 Class II — MOSAIQ Oncology Information System (May 21, 2026)
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  • Z-2712-2026 Class II — Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: (April 3, 2026)
  • Z-2711-2026 Class II — Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Appli (April 3, 2026)
  • Z-2006-2026 Class II — Brand Name: Leksell Vantage Arc System REF: 1053958 (March 19, 2026)
  • Z-1164-2026 Class II — Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Ele (December 14, 2025)
  • Z-1340-2026 Class II — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning (December 12, 2025)
  • Z-1339-2026 Class II — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning (December 12, 2025)
  • Z-1078-2026 Class II — MOSAIQ Oncology Information System with Particle Therapy License (License Kit 4 (December 10, 2025)
  • Z-0433-2026 Class II — Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotac (September 30, 2025)

FDA data resources