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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 23, 2016
Create Date January 10, 2017
Recall Status1 Terminated 3 on July 16, 2021
Recall Number Z-0987-2017
Recall Event ID 76085
510(K)Number K121448  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Oncentra External Beam Oncentra Brachy

Product Usage:
Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
Code Information All software builds
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		 Cross profile for Varian 60 degree wedge shows "horns."
FDA Determined
Cause 2		 Software design
Action Elekta sent an Urgent Important Safety Notification letter dated December 23, 2016 to affected customers. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The letter included an acknowledgement form to be returned to Elekta.
Quantity in Commerce 433
Distribution Worldwide Distribution - US Nationwide in the states of AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX, and the countries of Angola, Argentina, Armenia, Australia, Austria, Barbados, Belarus, Brazil, Bulgaria, Canada, China Columbia, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Kenya, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Yemen, 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
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