FDA Device recall Z-2153-2012
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0 by Varian Medical Systems Oncology Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2153-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-02 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems Oncology Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers/CODES: HIT0535, HIT2953 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2153-2012%22
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