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U.S. Department of Health and Human Services

Class 2 Device Recall ARIA Radiation Therapy Management

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  Class 2 Device Recall ARIA Radiation Therapy Management see related information
Date Initiated by Firm March 21, 2022
Create Date April 14, 2022
Recall Status1 Completed
Recall Number Z-0942-2022
Recall Event ID 89922
510(K)Number K133572  K173838  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Code Information DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165
Recalling Firm/
Manufacturer		 Varian Medical Systems Imaging Laboratory GmbH
Tafernstrasse 7
DATTWIL
Baden Switzerland
For Additional Information Contact vARIAN gLOBAL hELP dESK
441 293 601267
Manufacturer Reason
for Recall		 Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
FDA Determined
Cause 2		 Software Design Change
Action On 3/21/22, Varian Medical Systems issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the recall, Varian asked consignees to take the following actions: ¿ Please retain a copy of this document along with your most current product labeling. ¿ Advise the appropriate personnel working in your radiotherapy department of the content of this letter. ¿ This document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. ¿ Please complete the attached Return Response form provided. Kindly return the completed form to returnresponse@varian.com.
Quantity in Commerce 14
Distribution Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China.
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.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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