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Terminated

ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.

FDA Recall Z-0170-2016 · Posted 2015-10-30

Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2015-09-28
Date Terminated2017-05-12
Product Quantity1971 units

Reason for Recall

An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.

Firm Action

Varian sent an Urgent Medical Device Corrections letter dated September 29, 2015 via trackable method to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Varian is developing a technical correction for this issue. Customers will be contacted by a Varian Field Service. A copy of the notification is to be kept with the most current product labeling and all appropriate personnel in the radiation oncology department should be aware of this issue. For questions contact your local Varian Medical Systems Customer Support District or Regional Manager

Root Cause

Software design (manufacturing process)

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Switzerland, South Korea, Germany, Spain, Ireland, Spain, France, Belgium, United Arab Emirates, United Kingdom, Norway, Italy, Trinidad and Tobago, Netherlands, Philippines, Portugal, Denmark, Sweden, Belgium, Saudi Arabia, Thailand, Australia, India, Taiwan, South Africa, Israel, Australia, Kuwait, Finland, Tunisia, Algeria, Argentina, Bangladesh, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Guam, Guatemala, Hong Kong, Indonesia, Japan, Kazakhstan, Kuwait, Lebanon, Luxembourg, Madagascar, Moldova, Morocco, New Zealand, Panama, Poland, Qatar, Romania, Russia, Singapore, South Africa, Tunisia and Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093527ARIA RADIATION ONCOLOGY WITH MIRSVarian Medical Systems, Inc. · 2009-12-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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