Recall Z-0312-2012 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures.
| Date | Nov 30, 2011 (initiated May 26, 2011) |
| Status | Terminated |
| Reason | Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient. |
| Root cause | Pending |
| Action | Elekta sent an IMPORTANT NOTICE: Urgent Field Safety Notice letter dated May 12, 2011 to affected customers. The notice identified the affected product, problem, and actions to be taken by the user. The letter describes special care to be used in operating the helmet changer actuator LMR03. The letter states that Elekta will replace all actuators LMRO3. For more details contact your local Elekta representative. . |
| Quantity | 44 |
| Distribution | Nationwide Distribution (USA) - including the states of: CA, CO, DAL, FL, GA, IL, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA, WI and Puerto Rico |
| 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 |