—#90081

Product

Leksell Gamma Knife C

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K984328
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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installed base with the new type of actuator and to finish the remaining sites never or partially updated by the now superseded FCO-0000748.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.

Recalling firm

Firm: Elekta, Inc.
Address: 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

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

Timeline

Recall initiated: 2006-08-01
Posted by FDA: 2010-04-22
Terminated: 2010-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90081. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.