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U.S. Department of Health and Human Services

Class 2 Device Recall Oncentra Brachy 4.5

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  Class 2 Device Recall Oncentra Brachy 4.5 see related information
Date Initiated by Firm August 10, 2017
Create Date October 26, 2017
Recall Status1 Terminated 3 on November 20, 2020
Recall Number Z-0050-2018
Recall Event ID 78087
510(K)Number K132816  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V.

Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
Code Information Versions 4.5, 4.5.1, and 4.5.2.
Recalling Firm/
Manufacturer		 Nucletron BV
Waardgelder 1
POBox 930
Veenendaal Netherlands
For Additional Information Contact Ms. Alejandra Carrillo
770-670-2359
Manufacturer Reason
for Recall		 Incorrect source step size may occur in the software plans
FDA Determined
Cause 2		 Software design
Action Elekta sent an Field Safety Notice notification dated August 2017, and was emailed to customers on August 10, 2017, informed users of the issue and workarounds that can be used to avoid the issue.The user is informed the issue will be resolved in a fix which will be released by the end of February 2018. Once released, the firm will proactively reach out to all affected customers to arrange a time to install the fix. An acknowledgement form was enclosed which the user was to complete to indicate they have read and understood the notice and accept implementation of any given recommendations. For further questions, please call (770) 670-2359.
Quantity in Commerce 89 customer sites have the affected software
Distribution Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam. There was no military/government distribution.
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 = NUCLETRON B.V.
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