Drug recall
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA…
FDA recall event 62562 · Class II · Varian Medical Systems, Inc. Oncology Systems
Key facts
| Event ID | 62562 |
|---|---|
| Recall numbers | Z-2153-2012 |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jul 2, 2012 |
| Report date | Aug 15, 2012 |
| Termination date | Jul 1, 2013 |
| City | Palo Alto |
| State | CA |
| Country | United States |
| FEI number | 2916710 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: