Elekta, Inc. Leksell Gamma Knife C Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leksell Gamma Knife C
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
4149, 4150, 4151, 4157, 4158, 4160, 4151, 4165, 4168, 4171, 4175, 4176, 4178, 4183, 4187, 4189, 4191, 4193, 4194, 4195, 4196, 4197, 4199, 4201, 4202, 4204, 4207, 4208, 4212, 4300, 4302, 4303, 4306, 4307, 4308, 4309, 4313, 4314, 4315, 4318, 4319, 4321, 4322, 4326, 4328, 4329, 4334, 4337, 4802, 4809, 4816, 4817, 4818, 4824, 4828, 4830, 5000, 5003, 5006, 5009, 5010, 5001, 4803, 4310, 4210, 4311, 4330, 5004, 5014, 4305, 4320, 4317, 4324, 4325, 5011, 5012, 4304, 4316, 5002, 5007, 5008, 5013, 4819, 4806, 5005, 4301, 4323, 4312
Products Sold
4149, 4150, 4151, 4157, 4158, 4160, 4151, 4165, 4168, 4171, 4175, 4176, 4178, 4183, 4187, 4189, 4191, 4193, 4194, 4195, 4196, 4197, 4199, 4201, 4202, 4204, 4207, 4208, 4212, 4300, 4302, 4303, 4306, 4307, 4308, 4309, 4313, 4314, 4315, 4318, 4319, 4321, 4322, 4326, 4328, 4329, 4334, 4337, 4802, 4809, 4816, 4817, 4818, 4824, 4828, 4830, 5000, 5003, 5006, 5009, 5010, 5001, 4803, 4310, 4210, 4311, 4330, 5004, 5014, 4305, 4320, 4317, 4324, 4325, 5011, 5012, 4304, 4316, 5002, 5007, 5008, 5013, 4819, 4806, 5005, 4301, 4323, 4312
Elekta, Inc. is recalling Leksell Gamma Knife C due to Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock hel. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. Lock did not fully engage and could still be raised. When the lock does not engage, then when the helmet changer rises, the helmet could disengage from the helmet changer and fall back onto the helmet trolley.
Recommended Action
Per FDA guidance
Phase 1 - Field Change Order FCO-DOC-06-0003 "Technical Note - Potential risk of dropping the collimator helmet" (dated Aug. 28, 2006) was sent to affected customers as notification of the problem. Phase 2 - Technical Notes Leksell Gamma Knife C version 1.2 (dated July 2006) "Important Notice - Potential risk of dropping the collimator helmet" was sent to all Elekta Service Engineers as notification of the problem. The firm planned to create an upgrade kit for the effected Leksell Gamma Knife C1.2 systems. A service representative from Elekta will contact each site to decide on a suitable implementation schedule.
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