Varian ARIA Oncology Software Recall Due to Incorrect MLC Data Import
Varian Medical Systems is recalling two units of ARIA Oncology Information System software due to a defect that incorrectly imports MLC leaf positions for specific treatment plans.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to incorrect treatment plan data, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Varian Medical Systems, Inc. is recalling two units of the Varian ARIA Oncology Information System, Import Export application, version 11.0. The affected software is identified by Reference/FSCA Identifier CP-08847 and Model Number HIT. The specific units involved have serial numbers HIT0535 and HIT2953.
The recall was initiated because a software anomaly was identified in the Import Export Application. This defect causes MLC (multi-leaf collimator) leaf positions to be incorrectly imported for treatment plans that use BrainLab m3 and mMLC. The ARIA system is a treatment plan and image management application used to enter, access, modify, store, and archive treatment plan and image data.
The affected software was distributed nationwide, including in the states of New York and Ohio. Because the source text does not specify the exact actions consumers or healthcare providers should take, users of this software should contact Varian Medical Systems, Inc. for further instructions on how to resolve the issue.
The recalled product
- 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 t
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Category
- Medical Device — Software
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Numbers/CODES: HIT0535
- HIT2953
Distribution
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