| | Class 2 Device Recall Leksell Gamma Knife |  |
| Date Initiated by Firm | February 18, 2026 |
|---|
| Date Posted | March 19, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1581-2026 |
|---|
| Recall Event ID |
98443 |
| 510(K)Number | K250391 |
|---|
| Product Classification |
System, radiation therapy, radionuclide - Product Code IWB
|
| 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. |
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| 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
|
| FEI Number |
1037831
|
Recalling Firm/
Manufacturer |
Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
|
| For Additional Information Contact | Elekta Care Support
001-855-6935358 |
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Manufacturer Reason
for Recall | Due to adapter not being properly aligned or locked in place. |
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FDA Determined
Cause 2 | Use error |
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| Action | On 02/18/2026 and 02/24/2026, the firm sent via email an "IMPORTANT FIELD SAFETY NOTIFICATION/URGENT: MEDICAL DEVICE CORRECTION" letter to customers informing them that Elekta has become aware that a Quality Assurance (QA) procedure was initiated while the adapter was not properly locked to the Patient Positioning System of the Leksell Gamma Knife and as a result, the QA check failed.
Customers are instructed to:
To prevent the risk of incorrect locking, it is important to always check that the patient is properly attached to the Leksell Gamma Knife. The adapter shall be perfectly aligned with the docking device. Reference instructions for use and warnings:
Warning 4.1 - After locking the docking device, make sure that the adapter is correctly attached and securely locked to the patient positioning system. if the adapter is not correctly locked, it may affect the accuracy and lead to clinical mistreatment, or cause patient injury.
All Customer must print/save this page and add it to their existing IFU file.
For questions - Contact Region America at Application.Support.NA@elekta.com or telephone +1 855-693-5358 |
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| Quantity in Commerce | 352 |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = IWB
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