Varian ARIA Radiation Oncology Software Recall Due to Treatment Plan Error
Varian Medical Systems is recalling ARIA Radiation Oncology Version 11 software because monitor units may be incorrect when continuing partial treatment.
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 radiation dosing (risk of harm), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Varian Medical Systems, Inc. Oncology Systems is recalling 205 units of ARIA Radiation Oncology, Version 11. This product is a treatment plan and image management application used in radiation oncology. The recall covers units distributed worldwide, including the United States, Australia, Denmark, and the United Kingdom.
The recall was initiated because an anomaly was identified where Monitor Units of one fraction may be incorrect when partial treatment is being continued. This software error could affect the accuracy of radiation treatment plans.
Healthcare facilities and users of the ARIA Radiation Oncology software should contact Varian Medical Systems for instructions on how to address the anomaly and ensure treatment plans are accurate.
The recalled product
- Product
- ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 205
Distribution
Distributed nationwide across the United States.
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