Varian ARIA Radiation Oncology Software Recall for Printing Anomaly
Varian Medical Systems is recalling ARIA Radiation Oncology software versions 10, 11, 13.0, and 13.5 because admin instructions may fail to print or transmit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software printing/transmission failure for administrative instructions, which is a functional defect without reported injuries or deaths, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Varian Medical Systems, Inc. is recalling ARIA Radiation Oncology software, model number HIT, versions 10, 11, 13.0, and 13.5 with a Clinical Assessment License. The recall affects 1,971 units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because an anomaly was identified where Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx. This software is used for radiation treatment planning and image management.
Healthcare facilities using the affected software versions should contact Varian Medical Systems for further instructions regarding the anomaly.
The recalled product
- Product
- ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
- Manufacturer
- Varian Medical Systems, Inc.
- Category
- Medical Device — Software
- Affected units
- 1,971
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 (3)
- Model number HIT: All units with software version 10
- 11
- 13.0 and 13.5 with Clinical Assessment license.
Distribution
Distributed nationwide across the United States.
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