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U.S. Department of Health and Human Services

Class 2 Device Recall Dynamic Multileaf Collimator (DMLC)

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  Class 2 Device Recall Dynamic Multileaf Collimator (DMLC) see related information
Date Initiated by Firm May 25, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-0014-2012
Recall Event ID 59949
510(K)Number K001163  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Dynamic Multileaf Collimator (DMLC)

Shapes the radiation beam in treatment therapy.
Code Information 116001, 116012, 116044, EM7-008, 116055, 116064, 116014, 116052, 116023, 116056, 116053, 116047, 116043, 116051, 116070, 116122, 116063, 116020, EM7-003, EM-029, EM7-006, 116024, 116068, 116013, EM3-026, EM3-004, 116046
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-670-2548
Manufacturer Reason
for Recall		 It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).
FDA Determined
Cause 2		 Device Design
Action Elekta, Inc. sent an "IMPORTANT NOTICE" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter recommends several precautions customers should use until Elekta finds a solution. Customers will be contacted when a solution is found.
Quantity in Commerce 27
Distribution Nationwide Distribution-USA including the state of CT, FL, GA, IA, MN, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA , and WA.
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 = MUJ and Original Applicant = 3D LINE USA, INC.
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