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U.S. Department of Health and Human Services

Class 2 Device Recall Oncentra External Beam Treatment Planning Software

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  Class 2 Device Recall Oncentra External Beam Treatment Planning Software see related information
Date Initiated by Firm December 18, 2015
Create Date January 07, 2016
Recall Status1 Terminated 3 on September 15, 2021
Recall Number Z-0604-2016
Recall Event ID 72869
510(K)Number K121448  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Oncentra External Beam - VMAT - Radiation therapy planning system

Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Code Information Versions 3.3 and higher
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
770-300-9725
Manufacturer Reason
for Recall		 When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.
FDA Determined
Cause 2		 Software design
Action Elekta sent an Important Field Safety Notice 806-01-ETP-001 to all affected customers on December 18, 2015. The notice informs users of the issue and that should the issue occur it could result in overdosage of organs at risk outside the intended treatment volume. Users are strongly advised to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient. To prevent the issue from occurring, the workaround is to not use the Tumor Overlap Fraction for VMAT planning.and not to use the Tumor Overlap Fraction for VMAT planning. The issue will be solved in Oncentra External Beam version 4.5.2. The notice included an acknowledgement form which is to be returned to Elekta. For questions contact your local Elekta representative.
Quantity in Commerce 154
Distribution Worldwide Distribution - US Nationwide in the states of CA, NY, PA, and the countries of Austria, Belarus, Canada, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden 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 = ELEKTA INC. D/B/A NUCLETRON CORPORATION
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