FDA Device recall Z-0170-2016
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License by Varian Medical Systems, citing 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 tran….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0170-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-28 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
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 a radiation treatment plan and image management application.
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.
Identifiers
| code_info | Model number HIT: All units with software version 10, 11, 13.0 and 13.5 with Clinical Assessment license. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0170-2016%22
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