Recall record at a glance
| Official record | Z-0170-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Varian Medical Systems, Inc. |
| Report date | Nov 4, 2015 |
| Recall initiation date | Sep 28, 2015 |
| Quantity | 1971 units |
| Location | Palo Alto, CA, United States |
Official product description
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.
Why the product was 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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