| Class 2 Device Recall ARIA Radiation Therapy Management | |
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
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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
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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.
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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