Class 2 Device Recall Oncentra External Beam Treatment Planning Software

• Date Initiated by Firm: December 23, 2016
• Create Date: January 10, 2017
• Recall Status: Terminated 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: 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