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U.S. Department of Health and Human Services

Class 2 Device Recall Radionuclie radiation therapy system

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  Class 2 Device Recall Radionuclie radiation therapy system see related information
Date Initiated by Firm May 26, 2011
Date Posted November 30, 2011
Recall Status1 Terminated 3 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 2
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 and Original Applicant = ELEKTA INSTRUMENT AB
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