Class 2 Device Recall XiO Radiation Treatment Planning System

• Date Initiated by Firm: February 22, 2010
• Date Posted: March 25, 2010
• Recall Status: Terminated on August 24, 2011
• Recall Number: Z-1209-2010
• Recall Event ID: 55008
• 510(K)Number: K092132
• Product Classification: System,planning,radiation therapy treatment - Product Code MUJ
• Product: XiO Radiation Treatment Planning System, Release 4.51.00.
• Code Information: Release 4.51.00
• Recalling Firm/ Manufacturer: Computerized Medical Systems Inc; 13723 Riverport Drive; Suite 100; Maryland Heights MO 63043
• For Additional Information Contact: Christopher Ivicevich; 408-830-8023
• Manufacturer Reason for Recall: Inconsistent MLC positions, dose, and monitor units
• FDA Determined Cause: Software design
• Action: Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.
• Quantity in Commerce: Planning system is loaded 25 in locations
• Distribution: Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
• 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