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RecallWatchMedical Device Safety
Class IIOngoingZ-1581-2026

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

Elekta, Inc.Atlanta, GA, United StatesReported Mar 25, 2026 · 3 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI code
    353 affected lots
    07340048303019Perfexion/11868-004/6002Perfexion/12214-003/6007Perfexion/10567-026/6011Perfexion/10567-024/6014Perfexion/12451-001/6019Perfexion/10064-008/6021Perfexion/18630-001/6031
    +345 morePerfexion/11813-003/6034Perfexion/11007-005/6035Perfexion/10908-003/6045Perfexion/13337-LGK001/6052Perfexion/10762-005/6057Perfexion/11550-001/6065Perfexion/14878-003/6067Perfexion/11792-005/6077Perfexion/10356-007/6079Perfexion/10924-001/6089Perfexion/15045-LGK001/6091Perfexion/11848-003/6095Perfexion/12236-006/6097Perfexion/13558-001/6099Perfexion/20364-001/6103Perfexion/10848-LGK001/6108Perfexion/11390-LGK001/6109Perfexion/30002718-001/6113Perfexion/11433-LGK001/6116Perfexion/10643-005/6117Perfexion/11990-LGK001/6118Perfexion/12620-002/6120Perfexion/17322-001/6121Perfexion/105528-001/6122Perfexion/11999-001/6126Perfexion/10917-004/6128Perfexion/17357-001/6130Perfexion/10394-LGK01/6144Perfexion/30002934-ENS/6160Perfexion/10583-LGK002/6161Perfexion/16867-001/6166Perfexion/10929-LGK002/6175Perfexion/10424-001/6182Perfexion/17539-001/6185Perfexion/11377-003/6186Perfexion/16647-001/6187Perfexion/11733-001/6192Perfexion/10960-005/6193Perfexion/21061-001/6195Perfexion/11439-002/6196Perfexion/30000655-001/6199Perfexion/11731-005/6200Perfexion/11149-LGK002/6206Perfexion/11077-007/6207Perfexion/30001910-001/6208Perfexion/13514-001/6211Perfexion/10979-002/6213Perfexion/10208-003/6215Perfexion/11127-009/6219Perfexion/30000732-001/6223Perfexion/30001270-001/6225Perfexion/11420-001/6228Perfexion/30001527-001/6231Perfexion/10879-LGK002/6234Perfexion/10698-001/6237Perfexion/10711-002/6243Perfexion/10148-LGK002/6245Perfexion/12748-LGK001/6248Perfexion/11536-LGK002/6251Perfexion/10567-044/6253Perfexion/10425-LGK002/6254Perfexion/11434-LGK002/6255Perfexion/13031-LGK/6256Perfexion/11006-LGK002/6259Perfexion/30000722-003/6261Perfexion/10537-LGK002/6264Perfexion/30001107-002/6265Perfexion/10630-002/6266Perfexion/11524-002/8001Perfexion/12643-001/8010Perfexion/30003042-001/8011Perfexion/11695-LGK002/8015Perfexion/11322-002/8028Perfexion/10700-LGK002/8044Perfexion/12957-003/8053Perfexion/11787-003/8059Perfexion/30000346-001/8065Perfexion/30004796-RS001/8078Perfexion/11131-LGK002/8098Perfexion/13252-LGK001/8106Perfexion/30000269-LGK001/8109Perfexion/15490-003/8124Perfexion/30002079-LGK001/818007340048305587Icon/30004749-LGK001/8099Icon/14750-LGK001/8083Icon/12579-007/6250Icon/18850-500/8005Icon/11920-C5210/6088Icon/30004694-003/8064Icon/30000718-002/6246Icon/30004889-LGK001/8087Icon/14765-003/8027Icon/12473-003/6005Icon/12274-014/6209Icon/10611-001/6081Icon/11720-002/6143Icon/12846-004/6064Icon/12242-003/8085Icon/30005412-002/8114Icon/12178-002/8002Icon/12685-007/8105Icon/10545-009/8072Icon/12926-001/6212Icon/14915-003/6236Icon/30004236-003/8117Icon/30002968-004/8030Icon/12668-008/8178Icon/14983-500/6076Icon/11916-001/8056Icon/11083-HOM001/6070Icon/15554-001/8103Icon/15661-502/8121Icon/10247-002/6136Icon/30000736-003/8108Icon/30005910-001/8127Icon/11676-003/8040Icon/11976-502/8035Icon/11868-008/6131Icon/12947-003/8122Icon/11290-ENS1/6174Icon/18464-003/8066Icon/10795-K08002/6063Icon/30004024-RS01/6201Icon/11291-001/6018Icon/10326-003/6105Icon/21121-002/8067Icon/10783-003/8077Icon/30004796-RS001/8078Icon/30006128-500/8112Icon/30004887-LGK001/8069Icon/30006248-500/8125Icon/30000656-500/6227Icon/17414-004/8043Icon/17525-002/6038Icon/12629-003/6026Icon/15514-003/8034Icon/17522-001/6214Icon/20438-003/6013Icon/10416-LGK001/6125Icon/15748-LGK001/6106Icon/11019-LGK002/8071Icon/10997-LGK001/6087Icon/10832-LGK002/8115Icon/11992-LGK002/8029Icon/10654-LGK002/8100Icon/14900-LGK001/6058Icon/11230-LGK002/8025Icon/12958-LGK002/8096Icon/11639-LGK001/6042Icon/13480-LGK003/8095Icon/11892-LGK002/8057Icon/11414-LGK002/6205Icon/11986-LGK003/8088Icon/11143-LGK002/6257Icon/11991-LGK003/8084Icon/10362-LGK002/8039Icon/10959-LGK001/6132Icon/11784-LGK001/6055Icon/10648-LGK001/6098Icon/10514-LGK002/6183Icon/30000333-LGK002/8119Icon/10103-LGK02/6149Icon/30001254-001/8092Icon/10104-LGK002/8046Icon/11530-001/6101Icon/19100-LGK001/8033Icon/10234-002/6111Icon/11586-001/6157Icon/15416-001/6086Icon/10444-LGK004/8003Icon/10728-001/6062Icon/11352-001/6044Icon/17033-LGK002/8113Icon/10974-503/8061Icon/40017-002/6170Icon/17260-LGK001/8073Icon/19046-LGK001/8036Icon/11674-LGK001/8031Icon/12109-002/6169Icon/12959-002/6033Icon/10420-AVL-GK/6156Icon/10590-LGK-01/8097Icon/10209-001/6046Icon/30005199-LGK001/8090Icon/30001255-LGK001/8091Icon/30001751-002/6068Icon/30004975-LGK001/8102Icon/105618-001/6110Icon/19633-001/6154Icon/30003654-LGK001/8054Icon/14958-504/6155Icon/30004895-001/8104Icon/30000767-LGK001/6104Icon/30002955-001/8016Icon/11553-001/6024Icon/11582-LGK001/8111Icon/17032-LGK002/8129Icon/11418-LGK002/8051Icon/10476-LGK001/6263Icon/30007880-LGKVDH/8131Icon/10118-001/6230Icon/30007230-LGK001/8133Icon/19710-LGK002/8070Icon/13271-LGK01/8076Icon/12270-001/8050Icon/10886-013/6027Icon/18062-001/6146Icon/13160-001/6039Icon/14117-005/8055Icon/11090-005/6165Icon/10434-004/6244Icon/11328-020/8063Icon/11395-010/6032Icon/10568-007/8094Icon/12752-004/6242Icon/10817-009/6204Icon/10591-002/6083Icon/10567-038/6107Icon/14569-001/6135Icon/13779-002/8026Icon/11054-004/8038Icon/15053-001/6179Icon/10039-004/8048Icon/10071-007/6119Icon/13120-011/8013Icon/11073-016/8080Icon/17674-003/8037Icon/30002346-001/8058Icon/10899-007/6260Icon/10597-002/6167Icon/10383-007/6100Icon/10383-009/8120Icon/10193-007/6056Icon/30000118-001/6240Icon/11039-006/6188Icon/10760-006/6173Icon/16717-002/8116Icon/10387-018/6093Icon/10894-003/8042Icon/11138-004/6115Icon/12269-002/6082Icon/11791-006/6022Icon/11834-004/6222Icon/10313-010/8136Icon/10909-024/8107Icon/10982-003/6053Icon/10176-002/8086Icon/11347-003/6134Icon/11256-001/6012Icon/12108-004/8041Icon/11360-004/6059Icon/10436-009/6150Icon/13553-005/6249Icon/11198-009/8081Icon/10673-022/8012Icon/14236-001/6114Icon/10492-003/8019Icon/19112-LGK001/806007340201501139Esprit/10711-LGK001/8195Esprit/30008463-0002/8179Esprit/30004455-LGK001/8148Esprit/10587-LGK001/8181Esprit/12236-LGK013/8197Esprit/14874-005/8138Esprit/14857-003/8160Esprit/30006645-LGK001/8196Esprit/10684-002/6090Esprit/30002563-LGK001/8144Esprit/18649-004/8139Esprit/20116-001/8192Esprit/30006828-001/8167Esprit/11154-GK007/8151Esprit/30002306-LGK001/8164Esprit/11563-LGK003/8171Esprit/11670-LGK002/8166Esprit/10375-LGK002/8126Esprit/30006511-LGK001/8149Esprit/15104-LGK002/8147Esprit/30008296-LGK001/6223Esprit/19115-LGK001/8193Esprit/12028-LGK002/6217Esprit/10523-LGK001/8187Esprit/10459-LGK002/8152Esprit/10158-LGK/8163Esprit/40023-LGK002/8162Esprit/10444-001/8185Esprit/11352-LGK002/8154Esprit/17033-003/8183Esprit/11245-LGK001/8017Esprit/13125-NUC001/8158Esprit/12027-ETZ-G2/8134Esprit/12946-LGK001/8014Esprit/30005168-503/8172Esprit/10076-GK002/8045Esprit/11234-LGK001/8130Esprit/10779-08/8024Esprit/13370-006/8173Esprit/30002888-LGK001/6159Esprit/30001913-LGK001/8032Esprit/30003406-LGK002/8022Esprit/12766-LGK003/8123Esprit/10622-014/8140Esprit/11373-010/8145Esprit/11396-004/8176Esprit/10643-007/8191Esprit/11175-013/6229Esprit/30000171-003/6172Esprit/10349-007/8161Esprit/10636-007/8062Esprit/10567-053/6232Esprit/10567-050/8052Esprit/10567-048/8142Esprit/10567-054/8168Esprit/12164-005/8153Esprit/14030-004/8146Esprit/11714-005/8184Esprit/11092-004/8188Esprit/10255-013/8165Esprit/10877-012/8169Esprit/11740-003/8135Esprit/12864-LGK001/8186Esprit/10379-004/8137Esprit/13826-003/6239Esprit/10383-LGK012/6100Esprit/14153-003/8175Esprit/11798-014/8156Esprit/11888-007/6171Esprit/11710-006/8170Esprit/11077-009/8190Esprit/11030-011/8155Esprit/10542-015/6238Esprit/11201-006/6047Esprit/19485-002/8174Esprit/10909-013/8020Esprit/11293-008/8182Esprit/11226-004/8177Esprit/11820-008/8006Esprit/11772-007/8143Esprit/11198-008/8082Esprit/10673-031/8141Esprit/30006566-003/8118Esprit/11848-007/6095Esprit/10714-013/8159

What the firm is doing

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

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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