Class 2 Device Recall Oncentra External Beam

• Date Initiated by Firm: August 21, 2012
• Date Posted: October 23, 2012
• Recall Status: Terminated 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
• FEI Number: 1037831
• 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: 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