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U.S. Department of Health and Human Services

Class 2 Device Recall XiO Radiation Treatment Planning System

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  Class 2 Device Recall XiO Radiation Treatment Planning System see related information
Date Initiated by Firm August 31, 2015
Create Date October 16, 2015
Recall Status1 Terminated 3 on September 15, 2021
Recall Number Z-0130-2016
Recall Event ID 72223
510(K)Number K102216  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product XiO Radiation Treatment Planning System.
Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Code Information Version 4.51 and higher
Recalling Firm/
Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
Manufacturer Reason
for Recall
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
FDA Determined
Cause 2
Software design
Action Consignees were notified via URGENT FIELD SAFETY ALERT, on 08/31/2015.
Quantity in Commerce 1440 units
Distribution Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, France, Gabon, Germany, Greece, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Macedonia, Malaysia, Mali, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, The United Kingdom, Ukraine, Venezuela and Vietnam.
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 = COMPUTERIZED MEDICAL SYSTEMS, INC.