Date Initiated by Firm |
March 21, 2022 |
Create Date |
April 14, 2022 |
Recall Status1 |
Completed |
Recall Number |
Z-0942-2022 |
Recall Event ID |
89922 |
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
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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
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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. |
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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.
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