ARIA Radiation Oncology recall: Software Issue
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is…
Why was ARIA Radiation Oncology recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model number HIT: All units with software version 10, 11, 13.0 and 13.5 with Clinical Assessment license.
- Product
- ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is…
- Recalling firm
- Varian Medical Systems, Inc.
- Quantity
- 1971 units
- Distribution
- 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.
- Recall date
- November 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)