Reported Aug 15, 2012 · Terminated
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier:…
Varian Medical Systems, Inc. Oncology Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. Oncology Systems · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0
- Reference/FSCA IdentifierCP-08847
- Model NumberHIT; 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
- Lot codes and dates
- Serial Numbers/CODES
HIT0535HIT2953
- Serial Numbers/CODES
- Amount recalled
- 2 Units.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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