Recall Z-1236-2010 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
| Date | Apr 13, 2010 (initiated Oct 1, 2007) |
| Status | Terminated |
| Reason | After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator. |
| Root cause | Other |
| Action | Field Change Order 0000203 "Replacement of obsolete actuator sleigh on Helmet Changer", was sent to all customers that were affected. Direct questions to Elekta, Inc. by calling 1-770-670-2548. |
| Quantity | 5 units |
| Distribution | United States (CA, TN, TX and WA) and Taiwan. |
| 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 |