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U.S. Department of Health and Human Services

Class 2 Device Recall Oncentra Brachy treatment planning system

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  Class 2 Device Recall Oncentra Brachy treatment planning system see related information
Date Initiated by Firm May 21, 2015
Date Posted June 04, 2015
Recall Status1 Terminated 3 on July 16, 2021
Recall Number Z-1712-2015
Recall Event ID 71318
510(K)Number K121448  K081281  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Code Information MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3
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		 Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
FDA Determined
Cause 2		 Other
Action Important User Notice, 806-03-BTP-001, was distributed to customers on 5/21/2015, A software patch is in development and is expected to be released end of November, 2015. Elekta service will work with customers to implement the patch on affected devices within 6 months of the patch release.
Quantity in Commerce 351
Distribution AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kosovo, Libya, Malaysia, Mexico, Morocco, Namibia, Nepal, New Zealand, Oman, Pakistan, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Suriname, Taiwan, Thailand, Tobago, Ukraine, Venezuela, Vietnam, Zambia
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
510(K)s with Product Code = MUJ and Original Applicant = NUCLETRON CORPORATION
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