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U.S. Department of Health and Human Services

Class 2 Device Recall Model DMLC IVErgo, Dynamic Multileaf Collimator

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 Class 2 Recall
Model DMLC IVErgo, Dynamic Multileaf Collimator
see related information
Date Posted February 25, 2014
Recall Status1 Open
Recall Number Z-0978-2014
Recall Event ID 65309
Premarket Notification
510(K) Number
K001163 
Product Classification Block, Beam-Shaping, Radiation Therapy - Product Code IXI
Product DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
Code Information Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046
Recalling Firm/
Manufacturer
Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta, Georgia 30346-1227
For Additional Information Contact Linda Wetsel
770-300-9725
Manufacturer Reason
for Recall
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422.
Quantity in Commerce 35 units
Distribution US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
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.
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