Elekta, Inc.: Leksell Gamma Knife C

Recall number

Z-1429-2010

Recalling firm

Elekta, Inc.

Product

Leksell Gamma Knife C

Status

Terminated

Initiated

2006-08-01

Posted

2010-04-22

Terminated

2010-12-14

Reason

Due to a material change in a critical component of the linear actuators the quality of said part was found to be inadequate.

Root cause

Other

Action

Phase 1 - Technical Notes Leksell Gamma Knife C version 1.2 (dated August 2006) "Potential Problem with Error Handling" was sent to all users. Phase 2 - Mandatory Field Action 0000748, "Helmet Changer Actuator, MTB and MCU SW Upgrade Kit was released December 3, 2007. This Field Change Order includes two mod kits and a software upgrade to provide a permanent solution to the issues. Phase 3 - Technical Note 200 068, "Safety issue with helmet host actuator", released on May 15, 2008. This Technical Note includes a warning to customers of a potential quality problem with the helmet hoist actuator that is installed in the Leksell Gamma Knife. Phase 4 - Mandatory Field Action 200 067, "Investigation and Correction of Helmet Changer Actuators", released on May 15, 2008. This FCO includes a list of user machines which must be monitored for quality issues and provides a solution for replacement of parts should a deficiency be detected. Phase 5 - Mandatory Field Action 200 075, "Helmet Changer Actuator, MTB and MCU SW upgrade, release two", released on September 16, 2008. This FCO applies to machines within specific serial number ranges. Due to a material change in FCO-0000748 and baselines (conducted without notice by the manufacturer) the quality of said part was found to be inadequate. After reversing the material change, FCO 200 075 is released to update the installed base with the new type of actuator and to finish the remaining sites never or partially updated by the now superseded FCO-0000748. For further information, contact Elekta R&D Jonas Hallstensson on phone no. +46 709 843 553 or via e-mail jonas.hallstensson AT elekta.com.

Quantity

51 units

Distribution

AL, CA, CO, CT, FL, GA, IL, MD, MA, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA

Lot, serial or model codes

4148, 4207, 4214, 4300, 4302, 4303, 4306, 4307, 4308, 4309, 4313, 4314, 4315, 4318, 4319, 4321, 4322, 4326, 4327, 4328, 4329, 4332, 4333, 4334, 4337, 4338, 4339, 4340, 4341, 4342, 4343, 4344, 4346, 4351, 4352, 4353, 4354, 4357, 4363, 4365, 4366, 5000, 5003, 5006, 5009, 5010, 5018, 5019, 5022, 5023, 5026

510(k) numbers

["K984328"]

PMA numbers

not on file

Product code

IWB

Firm FEI

1037831

Firm city

Norcross

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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