Recall Z-1533-2010 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife C
| Date | Apr 29, 2010 (initiated Sep 1, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 |
| Quantity | 88 units |
| Distribution | Nationwide, Austria, Belgium, Canada, China, Croatia, Italy, Japan, Korea, Norway, Spain, Sweden, Taiwan and Turkey. |
| 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 |