Elekta, Inc. Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032.
Products Sold
Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032.
Elekta, Inc. is recalling Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. due to There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.
Recommended Action
Per FDA guidance
Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. 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