Recall Z-1429-2010 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife C
| Date | Apr 22, 2010 (initiated Aug 1, 2006) |
| Status | Terminated |
| 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 a |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984328 | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 Elekta Instrument AB, May 21, 1999 |