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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta DMLC

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 Class 2 Recall
Elekta DMLC
see related information
Date Posted September 04, 2013
Recall Status1 Terminated on July 28, 2015
Recall Number Z-2157-2013
Recall Event ID 66048
Premarket Notification
510(K) Number
Product Classification Block, Beam-Shaping, 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/
Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta, Georgia 30346-1227
For Additional Information Contact Linda Wetsel
Manufacturer Reason
for Recall
Clinical mistreatment may occur when there are errors in the clinical work flow.
FDA Determined
Cause 2
DESIGN: 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IXI and Original Applicant = 3D LINE USA, INC.