{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218768", "product_res_number": "Z-1581-2026", "event_date_initiated": "2026-02-18", "event_date_posted": "2026-03-19", "recall_status": "Open, Classified", "res_event_number": "98443", "product_code": "IWB", "k_numbers": [ "K250391" ], "product_description": "Brand Name: Leksell Gamma Knife\nProduct Description: Leksell Gamma Knife Perfexion\nLeksell Gamma Knife Icon\"\nLeksell Gamma Knife Elekta Esprit\n\n\nLeksell 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.", "code_info": "Lot Code: 07340048303019 (Perfexion)\nProduct and Serial Numbers:\nLGK Perfexion/11868-004/6002\nLGK Perfexion/12214-003/6007\nLGK Perfexion/10567-026/6011\nLGK Perfexion/10567-024/6014\nLGK Perfexion/12451-001/6019\nLGK Perfexion/10064-008/6021\nLGK Perfexion/18630-001/6031\nLGK Perfexion/11813-003/6034\nLGK Perfexion/11007-005/6035\nLGK Perfexion/10908-003/6045\nLGK Perfexion/13337-LGK001/6052\nLGK Perfexion/10762-005/6057\nLGK Perfexion/11550-001/6065\nLGK Perfexion/14878-003/6067\nLGK Perfexion/11792-005/6077\nLGK Perfexion/10356-007/6079\nLGK Perfexion/10924-001/6089\nLGK Perfexion/15045-LGK001/6091\nLGK Perfexion/11848-003/6095\nLGK Perfexion/12236-006/6097\nLGK Perfexion/13558-001/6099\nLGK Perfexion/20364-001/6103\nLGK Perfexion/10848-LGK001/6108\nLGK Perfexion/11390-LGK001/6109\nLGK Perfexion/30002718-001/6113\nLGK Perfexion/11433-LGK001/6116\nLGK Perfexion/10643-005/6117\nLGK Perfexion/11990-LGK001/6118\nLGK Perfexion/12620-002/6120\nLGK Perfexion/17322-001/6121\nLGK Perfexion/105528-001/6122\nLGK Perfexion/11999-001/6126\nLGK Perfexion/10917-004/6128\nLGK Perfexion/17357-001/6130\nLGK Perfexion/10394-LGK01/6144\nLGK Perfexion/30002934-ENS/6160\nLGK Perfexion/10583-LGK002/6161\nLGK Perfexion/16867-001/6166\nLGK Perfexion/10929-LGK002/6175\nLGK Perfexion/10424-001/6182\nLGK Perfexion/17539-001/6185\nLGK Perfexion/11377-003/6186\nLGK Perfexion/16647-001/6187\nLGK Perfexion/11733-001/6192\nLGK Perfexion/10960-005/6193\nLGK Perfexion/21061-001/6195\nLGK Perfexion/11439-002/6196\nLGK Perfexion/30000655-001/6199\nLGK Perfexion/11731-005/6200\nLGK Perfexion/11149-LGK002/6206\nLGK Perfexion/11077-007/6207\nLGK Perfexion/30001910-001/6208\nLGK Perfexion/13514-001/6211\nLGK Perfexion/10979-002/6213\nLGK Perfexion/10208-003/6215\nLGK Perfexion/11127-009/6219\nLGK Perfexion/30000732-001/6223\nLGK Perfexion/30001270-001/6225\nLGK Perfexion/11420-001/6228\nLGK Perfexion/30001527-001/6231\nLGK Perfexion/10879-LGK002/6234\nLGK Perfexion/10698-001/6237\nLGK Perfexion/10711-002/6243\nLGK Perfexion/10148-LGK002/6245\nLGK Perfexion/12748-LGK001/6248\nLGK Perfexion/11536-LGK002/6251\nLGK Perfexion/10567-044/6253\nLGK Perfexion/10425-LGK002/6254\nLGK Perfexion/11434-LGK002/6255\nLGK Perfexion/13031-LGK/6256\nLGK Perfexion/11006-LGK002/6259\nLGK Perfexion/30000722-003/6261\nLGK Perfexion/10537-LGK002/6264\nLGK Perfexion/30001107-002/6265\nLGK Perfexion/10630-002/6266\nLGK Perfexion/11524-002/8001\nLGK Perfexion/12643-001/8010\nLGK Perfexion/30003042-001/8011\nLGK Perfexion/11695-LGK002/8015\nLGK Perfexion/11322-002/8028\nLGK Perfexion/10700-LGK002/8044\nLGK Perfexion/12957-003/8053\nLGK Perfexion/11787-003/8059\nLGK Perfexion/30000346-001/8065\nLGK Perfexion/30004796-RS001/8078\nLGK Perfexion/11131-LGK002/8098\nLGK Perfexion/13252-LGK001/8106\nLGK Perfexion/30000269-LGK001/8109\nLGK Perfexion/15490-003/8124\nLGK Perfexion/30002079-LGK001/8180\n\n07340048305587 (Icon)\nProduct and Serial Numbers:\nLGK Icon/30004749-LGK001/8099\nLGK Icon/14750-LGK001/8083\nLGK Icon/12579-007/6250\nLGK Icon/18850-500/8005\nLGK Icon/11920-C5210/6088\nLGK Icon/30004694-003/8064\nLGK Icon/30000718-002/6246\nLGK Icon/30004889-LGK001/8087\nLGK Icon/14765-003/8027\nLGK Icon/12473-003/6005\nLGK Icon/12274-014/6209\nLGK Icon/10611-001/6081\nLGK Icon/11720-002/6143\nLGK Icon/12846-004/6064\nLGK Icon/12242-003/8085\nLGK Icon/30005412-002/8114\nLGK Icon/12178-002/8002\nLGK Icon/12685-007/8105\nLGK Icon/10545-009/8072\nLGK Icon/12926-001/6212\nLGK Icon/14915-003/6236\nLGK Icon/30004236-003/8117\nLGK Icon/30002968-004/8030\nLGK Icon/12668-008/8178\nLGK Icon/14983-500/6076\nLGK Icon/11916-001/8056\nLGK Icon/11083-HOM001/6070\nLGK Icon/15554-001/8103\nLGK Icon/15661-502/8121\nLGK Icon/10247-002/6136\nLGK Icon/30000736-003/8108\nLGK Icon/30005910-001/8127\nLGK Icon/11676-003/8040\nLGK Icon/11976-502/8035\nLGK Icon/11868-008/6131\nLGK Icon/12947-003/8122\nLGK Icon/11290-ENS1/6174\nLGK Icon/18464-003/8066\nLGK Icon/10795-K08002/6063\nLGK Icon/30004024-RS01/6201\nLGK Icon/11291-001/6018\nLGK Icon/10326-003/6105\nLGK Icon/21121-002/8067\nLGK Icon/10783-003/8077\nLGK Icon/30004796-RS001/8078\nLGK Icon/30006128-500/8112\nLGK Icon/30004887-LGK001/8069\nLGK Icon/30006248-500/8125\nLGK Icon/30000656-500/6227\nLGK Icon/17414-004/8043\nLGK Icon/17525-002/6038\nLGK Icon/12629-003/6026\nLGK Icon/15514-003/8034\nLGK Icon/17522-001/6214\nLGK Icon/20438-003/6013\nLGK Icon/10416-LGK001/6125\nLGK Icon/15748-LGK001/6106\nLGK Icon/11019-LGK002/8071\nLGK Icon/10997-LGK001/6087\nLGK Icon/10832-LGK002/8115\nLGK Icon/11992-LGK002/8029\nLGK Icon/10654-LGK002/8100\nLGK Icon/14900-LGK001/6058\nLGK Icon/11230-LGK002/8025\nLGK Icon/12958-LGK002/8096\nLGK Icon/11639-LGK001/6042\nLGK Icon/13480-LGK003/8095\nLGK Icon/11892-LGK002/8057\nLGK Icon/11414-LGK002/6205\nLGK Icon/11986-LGK003/8088\nLGK Icon/11143-LGK002/6257\nLGK Icon/11991-LGK003/8084\nLGK Icon/10362-LGK002/8039\nLGK Icon/10959-LGK001/6132\nLGK Icon/11784-LGK001/6055\nLGK Icon/10648-LGK001/6098\nLGK Icon/10514-LGK002/6183\nLGK Icon/30000333-LGK002/8119\nLGK Icon/10103-LGK02/6149\nLGK Icon/30001254-001/8092\nLGK Icon/10104-LGK002/8046\nLGK Icon/11530-001/6101\nLGK Icon/19100-LGK001/8033\nLGK Icon/10234-002/6111\nLGK Icon/11586-001/6157\nLGK Icon/15416-001/6086\nLGK Icon/10444-LGK004/8003\nLGK Icon/10728-001/6062\nLGK Icon/11352-001/6044\nLGK Icon/17033-LGK002/8113\nLGK Icon/10974-503/8061\nLGK Icon/40017-002/6170\nLGK Icon/17260-LGK001/8073\nLGK Icon/19046-LGK001/8036\nLGK Icon/11674-LGK001/8031\nLGK Icon/12109-002/6169\nLGK Icon/12959-002/6033\nLGK Icon/10420-AVL-GK/6156\nLGK Icon/10590-LGK-01/8097\nLGK Icon/10209-001/6046\nLGK Icon/30005199-LGK001/8090\nLGK Icon/30001255-LGK001/8091\nLGK Icon/30001751-002/6068\nLGK Icon/30004975-LGK001/8102\nLGK Icon/105618-001/6110\nLGK Icon/19633-001/6154\nLGK Icon/30003654-LGK001/8054\nLGK Icon/14958-504/6155\nLGK Icon/30004895-001/8104\nLGK Icon/30000767-LGK001/6104\nLGK Icon/30002955-001/8016\nLGK Icon/11553-001/6024\nLGK Icon/11582-LGK001/8111\nLGK Icon/17032-LGK002/8129\nLGK Icon/11418-LGK002/8051\nLGK Icon/10476-LGK001/6263\nLGK Icon/30007880-LGKVDH/8131\nLGK Icon/10118-001/6230\nLGK Icon/30007230-LGK001/8133\nLGK Icon/19710-LGK002/8070\nLGK Icon/13271-LGK01/8076\nLGK Icon/12270-001/8050\nLGK Icon/10886-013/6027\nLGK Icon/18062-001/6146\nLGK Icon/13160-001/6039\nLGK Icon/14117-005/8055\nLGK Icon/11090-005/6165\nLGK Icon/10434-004/6244\nLGK Icon/11328-020/8063\nLGK Icon/11395-010/6032\nLGK Icon/10568-007/8094\nLGK Icon/12752-004/6242\nLGK Icon/10817-009/6204\nLGK Icon/10591-002/6083\nLGK Icon/10567-038/6107\nLGK Icon/14569-001/6135\nLGK Icon/13779-002/8026\nLGK Icon/11054-004/8038\nLGK Icon/15053-001/6179\nLGK Icon/10039-004/8048\nLGK Icon/10071-007/6119\nLGK Icon/13120-011/8013\nLGK Icon/11073-016/8080\nLGK Icon/17674-003/8037\nLGK Icon/30002346-001/8058\nLGK Icon/10899-007/6260\nLGK Icon/10597-002/6167\nLGK Icon/10383-007/6100\nLGK Icon/10383-009/8120\nLGK Icon/10193-007/6056\nLGK Icon/30000118-001/6240\nLGK Icon/11039-006/6188\nLGK Icon/10760-006/6173\nLGK Icon/16717-002/8116\nLGK Icon/10387-018/6093\nLGK Icon/10894-003/8042\nLGK Icon/11138-004/6115\nLGK Icon/12269-002/6082\nLGK Icon/11791-006/6022\nLGK Icon/11834-004/6222\nLGK Icon/10313-010/8136\nLGK Icon/10909-024/8107\nLGK Icon/10982-003/6053\nLGK Icon/10176-002/8086\nLGK Icon/11347-003/6134\nLGK Icon/11256-001/6012\nLGK Icon/12108-004/8041\nLGK Icon/11360-004/6059\nLGK Icon/10436-009/6150\nLGK Icon/13553-005/6249\nLGK Icon/11198-009/8081\nLGK Icon/10673-022/8012\nLGK Icon/14236-001/6114\nLGK Icon/10492-003/8019\nLGK Icon/19112-LGK001/8060\n\nLGK Esprit\nUDI-DI code: 07340201501139\nProduct and Serial Numbers:\nLGK Esprit/10711-LGK001/8195\nLGK Esprit/30008463-0002/8179\nLGK Esprit/30004455-LGK001/8148\nLGK Esprit/10587-LGK001/8181\nLGK Esprit/12236-LGK013/8197\nLGK Esprit/14874-005/8138\nLGK Esprit/14857-003/8160\nLGK Esprit/30006645-LGK001/8196\nLGK Esprit/10684-002/6090\nLGK Esprit/30002563-LGK001/8144\nLGK Esprit/18649-004/8139\nLGK Esprit/20116-001/8192\nLGK Esprit/30006828-001/8167\nLGK Esprit/11154-GK007/8151\nLGK Esprit/30002306-LGK001/8164\nLGK Esprit/11563-LGK003/8171\nLGK Esprit/11670-LGK002/8166\nLGK Esprit/10375-LGK002/8126\nLGK Esprit/30006511-LGK001/8149\nLGK Esprit/15104-LGK002/8147\nLGK Esprit/30008296-LGK001/6223\nLGK Esprit/19115-LGK001/8193\nLGK Esprit/12028-LGK002/6217\nLGK Esprit/10523-LGK001/8187\nLGK Esprit/10459-LGK002/8152\nLGK Esprit/10158-LGK/8163\nLGK Esprit/40023-LGK002/8162\nLGK Esprit/10444-001/8185\nLGK Esprit/11352-LGK002/8154\nLGK Esprit/17033-003/8183\nLGK Esprit/11245-LGK001/8017\nLGK Esprit/13125-NUC001/8158\nLGK Esprit/12027-ETZ-G2/8134\nLGK Esprit/12946-LGK001/8014\nLGK Esprit/30005168-503/8172\nLGK Esprit/10076-GK002/8045\nLGK Esprit/11234-LGK001/8130\nLGK Esprit/10779-08/8024\nLGK Esprit/13370-006/8173\nLGK Esprit/30002888-LGK001/6159\nLGK Esprit/30001913-LGK001/8032\nLGK Esprit/30003406-LGK002/8022\nLGK Esprit/12766-LGK003/8123\nLGK Esprit/10622-014/8140\nLGK Esprit/11373-010/8145\nLGK Esprit/11396-004/8176\nLGK Esprit/10643-007/8191\nLGK Esprit/11175-013/6229\nLGK Esprit/30000171-003/6172\nLGK Esprit/10349-007/8161\nLGK Esprit/10636-007/8062\nLGK Esprit/10567-053/6232\nLGK Esprit/10567-050/8052\nLGK Esprit/10567-048/8142\nLGK Esprit/10567-054/8168\nLGK Esprit/12164-005/8153\nLGK Esprit/14030-004/8146\nLGK Esprit/11714-005/8184\nLGK Esprit/11092-004/8188\nLGK Esprit/10255-013/8165\nLGK Esprit/10877-012/8169\nLGK Esprit/11740-003/8135\nLGK Esprit/12864-LGK001/8186\nLGK Esprit/10379-004/8137\nLGK Esprit/13826-003/6239\nLGK Esprit/10383-LGK012/6100\nLGK Esprit/14153-003/8175\nLGK Esprit/11798-014/8156\nLGK Esprit/11888-007/6171\nLGK Esprit/11710-006/8170\nLGK Esprit/11077-009/8190\nLGK Esprit/11030-011/8155\nLGK Esprit/10542-015/6238\nLGK Esprit/11201-006/6047\nLGK Esprit/19485-002/8174\nLGK Esprit/10909-013/8020\nLGK Esprit/11293-008/8182\nLGK Esprit/11226-004/8177\nLGK Esprit/11820-008/8006\nLGK Esprit/11772-007/8143\nLGK Esprit/11198-008/8082\nLGK Esprit/10673-031/8141\nLGK Esprit/30006566-003/8118\nLGK Esprit/11848-007/6095\nLGK Esprit/10714-013/8159", "firm_fei_number": "1037831", "recalling_firm": "Elekta, Inc.", "address_1": "400 Perimeter Center Ter NE Ste 50 400 Perimeter Center Ter NE", "address_2": "Ste 50", "city": "Atlanta", "state": "GA", "postal_code": "30346-1227", "additional_info_contact": "Elekta Care Support\n001-855-6935358", "reason_for_recall": "Due to adapter not being properly aligned or locked in place.", "root_cause_description": "Use error", "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.\n\nCustomers are instructed to:\nTo 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:\nWarning 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.\nAll Customer must print/save this page and add it to their existing IFU file.\n\nFor questions - Contact Region America at Application.Support.NA@elekta.com or telephone +1 855-693-5358", "product_quantity": "352", "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.", "openfda": { "k_number": [ "K232854", "K984563", "K150191", "K780948", "K964606", "K092083", "K190844", "K827583", "K960892", "K063512", "K850543", "K053485", "K001006", "K894165", "K142219", "K924849", "K120811", "K173791", "K914808", "K984328", "K180571", "K925133", "K131777", "K160440", "K863180", "K133565", "K200050", "K102533", "K151561", "K173789", "K912250", "K860849", "K250391", "K061941", "K041125", "K061540", "K172706", "K983917", "K973441", "K060314", "K151159", "K203250", "K222047", "K000478", "K871215", "K203146", "K970647", "K051022" ], "registration_number": [ "3005136058", "1038814", "3006946288", "9617016", "3014273653", "3015620182", "3015232217", "2939248", "3015621321", "3020999824" ], "fei_number": [ "3005136058", "1038814", "3006946288", "3014273653", "3002806900", "3015620182", "3015232217", "2939248", "3015621321", "3020999824" ], "device_name": "System, Radiation Therapy, Radionuclide", "medical_specialty_description": "Radiology", "regulation_number": "892.5750", "device_class": "2" } } ] }