• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Elekta DMLC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Elekta DMLC
see related information
Date Posted September 04, 2013
Recall Status1 Open
Recall Number Z-2157-2013
Recall Event ID 66048
Premarket Notification
510(K) Number
K001163 
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/
Manufacturer
Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta, Georgia 30346-1227
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Linda Wetsel
770-670-2422
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.
-
-