Varian brand ARIA Radiation Oncology — Class II medical device recall Z-0531-2013
Terminated recall by Varian Medical Systems, Inc. Oncology Systems, reported 2012-12-26. Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology
| Recall number | Z-0531-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2012-12-17 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2014-03-03 |
| Quantity | 264 units |
Product
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
Reason for recall
Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0531-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.