Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
- Company
- Elekta, Inc.
- Recall Initiated
- April 19, 2016
- Terminated
- July 16, 2021
- Recall Number
- Z-1561-2016
- Quantity
- 217
- Firm Location
- Atlanta, GA
Reason for Recall
The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.
Distribution
Worldwide Distribution - US Nationwide in the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WV, WI, and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
Lot / Code Info
Perfexion - 14753-099/6052, 12579-007/6250, 10394-LGK01/6144, 11920-C5210/6088, 17397-001/6158, 105528-001/6122, 14857-001/6028, 12236-006/6097, 12473-003/6005, 14857-001/6028, 16867-001/6166, 12668-003/6145 10208-003/6215, 10698-001/6237, 10979-002/6213, 10316-500/6210, 21061-001/6195, 20364-001/6103, 11720-002/6143, 12620-002/6120, 10611-001/6081, 12846-004/6064, 11524-002/8001, 11420-001/6212, 11420-001/6228, 14983-001/6076, 11083-HOM001/6070, 10247-002/6136,10684-002/6090,11868-004/6002, 10795-K08002/6063, 20354-ENS/6160, 11792-005/6077, 11291-001/6018, 10326-003/6105, 18630-001/6031, 17322-001/6121, 30000656-002/6227, 12629-003/6026, 10924-001/6089, 11154-003/6050, 20438-003/6013 17522-001/6214, 17525-002/6038, 11414-LGK002/6205, 11940-LGK002/6181, 10514-LGK002/6183, 11639-LGK001/6042, 11390-LGK001/6109, 10416-LGK001/6125, 11670-LGK001/6133, 11990-LGK001/6118, 10648-LGK001/6098, 15104-LGK001/6080, 10654-LGK001/6096, 10959-LGK001/6132, 10997-LGK001/6087, 15748-LGK001/6106, 11149-LGK002/6206, 11986-LGK002/6218, 10929-LGK002/6175, 10879-LGK002/6234, 11434-LGK002/6255, 11991-LGK002/6198, 13480-LGK002/6148, 10425-LGK002/6254, 10583-LGK002/6161, 11563-LGK002/6162, 10103-LGK02/6149, 10541-LGK002/6142, 10848-LGK001/6108, 11433-LGK001/6116, 14900-LGK001/6058, 15045-LGK001/6091 11784-LGK001/6055, 30000732-001/6223, 40017-002/6170, 12085-006/6163, 12109-002/6169, 12959-002/6033, 10209-001/6046, 10960-005/6193, 0002718-001/6113, 30001751-WOJ701/6068, 12451-001/6019, 14878-003/6067, 105618-001/6110, 19634-001/6155, 16647-001/6187, 14891-001/6104, 30001527-001/6231, 12028-LGK002/6217, 11586-001/6157, 10728-001/6062, 11999-001/6126, 15416-001/6086, 10459-001/6123, 10158-001/6177, 10234-002/6111, 40023-001/6178, 10444-001/6085, 17033-003/6043, 11530-001/6101, 11553-001/6024, 10779-07/6069, 13465-CHUV03/6094, 10424-001/6182, 13370-002/6075, 12214-003/6007, 30000655-001/6199, 10152-001/6159, 11550-001/6065, 10118-001/6230, 12766-001/6112, 13160-001/6039, 11042-001/6003, 12270-001/6017, 18062-001/6146, 11710-004/6141, 11820-006/8006, 11570-004/6220, 11127-009/6219, 12164-004/6221, 10434-004/6244, 10542-012/6238, 13826-002/6239, 10567-041/6191, 98300-003/6140, 10567-037/6119, 14569-001/6135, 10643-005/6117, 11798-009/6060, 17357-001/6130, 11813-003/6034, 10356-007/6079, 10567-045/6232, 10567-032/6074, 10567-030/6036, 10567-025/6029, 11293-004/6004, 12269-002/6082, 11772-004/6048, 10164-004/6009, 10349-003/6066, 10567-026/6011, 10560-003/6127, 11073-008/6020, 10567-036/6102, 14236-001/6114, 10567-035/6092, 10379-002/6061, 11030-006/6030, 13050-001/6037, 10909-009/6010, 11714-003/6072, 12985-003/6025, 14030-002/6015, 10567-031/6054, 10064-008/6021, 13558-001/6099, 10567-038/6107, 11939-003/6008, 10591-002/6083, 10567-024/6014, 11848-003/6095, 11624-003/6078, 10383-007/6100, 11395-010/6032, 11198-005/6124, 10982-003/6053, 11256-001/6012, 10905-004/6016, 10387-011/6093, 11138-004/6115, 10524-003/6073, 10908-003/6045, 10762-005/6057, 10193-007/6056, 10673-016/6006, 11007-005/6035, 11791-006/6022, 11377-003/6186, 12752-004/6242, 11039-006/6188, 10597-002/6167, 17539-001/6185, 14153-001/6197, 30000118-001/6240, 10567-039/6180, 15053-001/6179, 11731-005/6200, 11090-005/6165, 11077-007/6207, 30000171-002/6172, 10760-006/6173, 11733-001/6192, 10817-009/6204, 13514-001/6211, 10877-GK01/6151, 10436-009/6150, 11396-003/6176, 10917-004/6128, 11373-002/6184, 10567-042/6129, 10567-043/6203, 12614-003/6139, 10297-006/6171, 11347-003/6134 LEKSELL GAMMA KNIFE ICON - 11868-008/6131, 11290-ENS1/6174, 12027-EZT-G1/6041, 10444-LGK004/8003, 11352-001/6044, 10622-005/6194, 10886-013/6027, 11201-004/6047, 11834-003/6222
Root Cause
Use error
Action Taken
Elekta sent an Important User Notice (100-03-202-27) letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement Form attached. For questions contact your local Elekta office.