Recall Z-0170-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc.
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.
| Date | Oct 30, 2015 (initiated Sep 28, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design (manufacturing process) |
| 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 |
| 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, Thaila |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093527 | ARIA RADIATION ONCOLOGY WITH MIRS Varian Medical Systems, Inc., Dec 15, 2009 |