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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta DMLC

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  Class 2 Device Recall Elekta DMLC see related information
Date Initiated by Firm August 15, 2013
Date Posted September 04, 2013
Recall Status1 Terminated 3 on July 28, 2015
Recall Number Z-2157-2013
Recall Event ID 66048
510(K)Number K001163  
Product Classification Beam shaping block for Radiation Therapy. - Product Code IXI
Product DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Code Information EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
770-670-2422
Manufacturer Reason
for Recall		 Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
FDA Determined
Cause 2		 Device Design
Action Important Field Safety Notices 200 01 406 030 (Changes to your system to improve the safe operation of DMLC) and 200 01 602 031 (Changes to your system to improve the safe operation of 3DLINE DMLC) letters were sent to customers on 8/15/2013 advising them of the issue and recommendations to resolve either by upgrading their system or to discontinue a clinical use of the device.
Quantity in Commerce 31
Distribution Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA 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 = IXI and Original Applicant = 3D LINE USA, INC.
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