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.
This recall has been terminated (originally issued November 30, 2011).
- Company
- Elekta, Inc.
- Recall Initiated
- May 26, 2011
- Posted
- November 30, 2011
- Terminated
- October 6, 2014
- Recall Number
- Z-0312-2012
- Quantity
- 44
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient.
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
Lot / Code Info
4339, 4349, 5026, 4326, 5034, 4346, 4158, 4307, 4337, 4327, 4340, 5023, 5035, 5036, 4329, 4306, 4365, 4357, 5022, 4363, 4354, 4302, 4333, 4309, 4366, 4351, 4342, 4315, 4352, 4353, 4328, 5000, 4314, 4338, 4303, 4207, 4332, 4322, 4343, 4321, 4334, 4358
Root Cause
Pending
Action Taken
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. .