Elekta, Inc. Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device 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, Article #715000. Teletherapy device 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: 6002, 6003, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, and 6030.
Products Sold
Serial Numbers: 6002, 6003, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, and 6030.
Elekta, Inc. is recalling Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradi due to Need to modify the closing speed of the shielding doors in the event of an emergency exit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Need to modify the closing speed of the shielding doors in the event of an emergency exit
Recommended Action
Per FDA guidance
A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.
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 noticeDistribution
As reported by FDA
AZ, AR, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA
Page updated: Jan 10, 2026