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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 Recall
Oncentra External Beam
see related information
Date Posted October 23, 2012
Recall Status1 Terminated on November 03, 2014
Recall Number Z-0118-2013
Recall Event ID 63405
Premarket Notification
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, Georgia 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = NUCLETRON CORPORATION
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