Elekta, Inc.: 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.

Recall number

Z-1561-2016

Recalling firm

Elekta, Inc.

Product

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.

Status

Terminated

Initiated

2016-04-19

Posted

not on file

Terminated

2021-07-16

Reason

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.

Root cause

Use error

Action

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.

Quantity

217

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, serial or model codes

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

510(k) numbers

["K151159","K151561"]

PMA numbers

not on file

Product code

IWB

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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