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U.S. Department of Health and Human Services

Class 2 Device Recall ARIA Radiation Oncology

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  Class 2 Device Recall ARIA Radiation Oncology see related information
Date Initiated by Firm September 28, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 on May 12, 2017
Recall Number Z-0170-2016
Recall Event ID 72374
510(K)Number K093527  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License.
Model number HIT


Product Usage:
ARIA Radiation Oncology is a radiation treatment plan and image management application.
Code Information Model number HIT: All units with software version 10, 11, 13.0 and 13.5 with Clinical Assessment license.
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact K. Jeffrey Semone
650-424-6833
Manufacturer Reason
for Recall		 An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Varian sent an Urgent Medical Device Corrections letter dated September 29, 2015 via trackable method to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Varian is developing a technical correction for this issue. Customers will be contacted by a Varian Field Service. A copy of the notification is to be kept with the most current product labeling and all appropriate personnel in the radiation oncology department should be aware of this issue. For questions contact your local Varian Medical Systems Customer Support District or Regional Manager
Quantity in Commerce 1971 units
Distribution Worldwide Distribution - US Nationwide and the countries of: Canada, Switzerland, South Korea, Germany, Spain, Ireland, Spain, France, Belgium, United Arab Emirates, United Kingdom, Norway, Italy, Trinidad and Tobago, Netherlands, Philippines, Portugal, Denmark, Sweden, Belgium, Saudi Arabia, Thailand, Australia, India, Taiwan, South Africa, Israel, Australia, Kuwait, Finland, Tunisia, Algeria, Argentina, Bangladesh, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Guam, Guatemala, Hong Kong, Indonesia, Japan, Kazakhstan, Kuwait, Lebanon, Luxembourg, Madagascar, Moldova, Morocco, New Zealand, Panama, Poland, Qatar, Romania, Russia, Singapore, South Africa, Tunisia and Turkey.
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 = VARIAN MEDICAL SYSTEMS, INC.
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