Elekta, Inc. Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os 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, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os 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 and 6036.
Products Sold
Serial Numbers: 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032 and 6036.
Elekta, Inc. is recalling Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta due to Radiation unit doors could close too fast on emergency exit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Radiation unit doors could close too fast on emergency exit.
Recommended Action
Per FDA guidance
Field Change Order 200 070 "MCU CS SW 8.3" dated September 11, 2008 was released. Consignees were informed of the necessary steps to avoid further issues relating to the affected product. 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