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.
This recall has been terminated (originally issued August 8, 2012).
- Recall Initiated
- July 2, 2012
- Posted
- August 8, 2012
- Terminated
- July 1, 2013
- Recall Number
- Z-2153-2012
- Quantity
- 2 Units.
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including the states of New York and Ohio.
Lot / Code Info
Serial Numbers/CODES: HIT0535, HIT2953
Root Cause
Software design
Action Taken
Varian Medical Systems sent a " Urgent Medical Device Correction Urgent Field Safety Notice" dated July 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed until a correction is deployed all treatment plans using the BrainLab m3 mMLC must be imported using the Import Wizard only. Varian Medical Systems is developing a technical correction for this issue. You will be contacted by a Customer Service Representative when this correction is available to schedule its installation on your system. For further questions please call 1.888.827.4265.