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U.S. Department of Health and Human Services

Class 2 Device Recall FOCAL Workstation

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  Class 2 Device Recall FOCAL Workstation see related information
Date Initiated by Firm August 18, 2014
Date Posted September 03, 2014
Recall Status1 Terminated 3 on August 08, 2017
Recall Number Z-2574-2014
Recall Event ID 68984
510(K)Number K013112  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product FOCAL Sim Workstation, Radiation Treatment Planning System.

Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Code Information Software versions 4.70.00 & 4.80.00
Recalling Firm/
Manufacturer
Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
404-933-5886
Manufacturer Reason
for Recall
When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
FDA Determined
Cause 2
Software design
Action Elekta, Inc. issued an Urgent Important Field Safety Notice letter (IFSN 382-01-MON-001) to all affected customers.. Confirmation of receipt is to be completed by October 31, 2014. The problem will be resolved in a patch to Focal 4.80. Development is underway with a release date of September 2014 with confirmation of installation of the patch for the fix no later than 6 months from release of the patch. An updated notice from the manufacturer is also being sent to affected customers (FCO: 382-01-MON-001 VID:2.0). For questions contact your local Elekta office.
Quantity in Commerce 554 units
Distribution Worldwide Distribution - US (nationwide)in the states of AK, CA, FL, MI, MN, MO, NJ, NY, NC, OH, PA, TN, VA,WA and Puerto Rico, Algeria, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech republic, Ecuador, Egypt, Estonia, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Pakistan Portugal, Romania, Russia, Saudi Arabia, Singapore, Solvenia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom
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 = COMPUTERIZED MEDICAL SYSTEMS, INC.
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