Varian brand Varian ARIA Oncology Information System — Class II medical device recall Z-2153-2012
Terminated recall by Varian Medical Systems, Inc. Oncology Systems, reported 2012-08-15, distributed nationwide. A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf position
| Recall number | Z-2153-2012 |
|---|---|
| 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 | 2012-07-02 |
| Classified | 2012-08-07 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Reason classes | software |
| Serial numbers | HIT0535, HIT2953 |
Product
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
Reason for recall
A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported.
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-2153-2012. 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.