ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies.
FDA Recall Z-2763-2011 · Posted 2011-07-08
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-05-17
Date Terminated2012-03-15
Product Quantity357
Reason for Recall
An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the "Convert to Setup Field" option, a Set-up field is created, that removes the DMLC plan components in order to create an open collimator field for setup purposes.
Firm Action
Varian Medical Systems, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 17, 2011, via Certified Mail to US; Federal Express to Canada. Foreign distribution will be handled by Varian Managers. The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc at 888- 827-4265.
***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- USA (nationwide) and countries of Algeria, Australia, Austria, Belgium, Brazil, Chile, China, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan Jordan, Kuwait, Malaysia, Morocco, Netherlands, Oman, Pakistan, Panama, Portugal, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunsia, Turkey, Ukraine, United Arab Emirates, and 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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