Reported May 4, 2016 · Terminated
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation…
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- 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.
- Lot codes and dates
- 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
- Amount recalled
- 217
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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