Class 2 Device Recall Radionuclie radiation therapy system

• Date Initiated by Firm: May 26, 2011
• Date Posted: November 30, 2011
• Recall Status: Terminated on October 06, 2014
• Recall Number: Z-0312-2012
• Recall Event ID: 60128
• 510(K)Number: K984328
• Product Classification: System, radiation therapy, radionuclide - Product Code IWB
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Elekta, Inc.; 4775 Peachtree Industrial Blvd; Bldg 300, #300; Norcross GA 30092-3011
• For Additional Information Contact: Thoma Valentine; 770-670-2548
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IWB