Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring parameters and preventing the device from commencing radiation treatment plan inappropriately.
FDA Recall Z-2194-2008 · Posted 2008-09-04
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-05-21
Date Terminated2010-11-27
Product Quantity241 units
Reason for Recall
Dose delivery may be altered after import from a third party planning system during radiation therapy.
Firm Action
Recall was initiated on May 21, 2008. A product notification letter (sent via certified mail) was distributed to all affected users, with description of the problem i.e., dose delivery may be altered after import from a third party planning system during radiation therapy . The letter was also distributed to Varian Sites, Marketing and Service Organizations. A software upgrade is currently being developed. For assistance, contact Varian Medical Systems, Oncology Systems at 1-650-424-5731.
Root Cause
Software design
Distribution Pattern
US and to Canada, Australia, Bahrain, Belorussia, Colombia, Finland, Germany, Greece, India, Italy, Japan, Kuwait, Lithuania, Mexico, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and the UK.
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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