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U.S. Department of Health and Human Services

Class 2 Device Recall Oncentra External Beam

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  Class 2 Device Recall Oncentra External Beam see related information
Date Initiated by Firm August 21, 2012
Date Posted October 23, 2012
Recall Status1 Terminated 3 on November 03, 2014
Recall Number Z-0118-2013
Recall Event ID 63405
510(K)Number K081281  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Oncentra External Beam 4.1.

Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Code Information None as the product is software
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-300-9725
Manufacturer Reason
for Recall		 During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
FDA Determined
Cause 2		 Software design
Action Nucletron sent a Customer Information Bulletin 555.00248 to all affected customers. The bulletin identified the product, problem, and actions to be taken by the customers. The bulletin contained information on how an incorrect dose association can be prevented by not renumbering beams during recalculation. A Read Confirmation Form was included for customers to complete and return. Contact your local Nucleton Service Representative for questions regarding this notice.
Quantity in Commerce 52 units
Distribution Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA.
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 CORPORATION
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