ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
FDA Recall Z-0187-2013 · Posted 2012-11-01
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-09-24
Date Terminated2013-12-05
Product Quantity205
Reason for Recall
An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
Firm Action
"Urgent Medical Device Correction/ Urgent Field Safety Notice" letters were sent on September 24, 2012 by Certified Mail with return receipt to all affected users. The problem was described and recommended user actions were provided. The notification letters were to also be distributed to Varian Sales, Marketing, and Service organizations. US customers may contact the Varian help desk at 1-(888) 827-4265.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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