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.
Enforcement
- Recall Number
- Z-1561-2016
- Event ID
- 73761
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Elekta, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 4, 2016
- Initiation Date
- April 19, 2016
- Classification Date
- April 22, 2016
- Termination Date
- July 16, 2021
- Address
- 400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, 30346-1227, United States
Description
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.
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.
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
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
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