Radionuclide Radiation Therapy System Product The recall
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging…
Why was Radionuclide Radiation Therapy System Product The 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging…
- Recalling firm
- Elekta, Inc.
- 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
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)