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Terminated

ARIA versions 8.0 and 8.1 Varian Medical Systems, Palo Alto, CA 94304 The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provided tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

FDA Recall Z-1905-2011 · Posted 2011-04-07

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-02-18
Date Terminated2012-06-19
Product Quantity645

Reason for Recall

An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect.

Firm Action

Varian Medical Systems sent an Urgent Medical Device Correction letter dated February 18, 2011, to all affected customers via Federal Express.. The letter identified the product, the problem, and the action to be taken by the customer. Varian has made design changes to address the issue in ARIA Radiation Oncology versions 8.2 and later. A corrective action will be undertaken to upgrade all affected items. For questions regarding this recall call US and Canada 1-888-VARIAN5 (888-827-4265. Europe +41 41 749 8844

Root Cause

Other

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Azerbaijan, Bahrain, Bangladesh, Barius, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, HOng Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Lithania, Malaysia, Maurtama, Morocco, Netherlands, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.

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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