Elekta, Inc. Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6049, 6053, 6054, 6056, 6057, 6059 and 6061.
Products Sold
Serial Numbers: 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6049, 6053, 6054, 6056, 6057, 6059 and 6061.
Elekta, Inc. is recalling Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekt due to There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.
Recommended Action
Per FDA guidance
Elekta, Inc. issued a Field Change Order 200 091 titled "Update Frame Adapter with New Frame Fixation Axle" dated November 6, 2009. Consignees were given instructions to prevent further issues related to the affected device. For further information, contact Elekta, Inc. at 1-770-300-9725.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026