ARIA Radiation Therapy Management Software May Cause Treatment Location Error
Varian ARIA radiation therapy management software versions 13.6 through 16.1 may generate incorrect treatment plan values that could direct radiation therapy to the wrong location. No illnesses have been reported.
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 3/5 (High).
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: This is a Class II medical device recall with potential for serious harm but no reported illnesses or injuries. The software defect could result in radiation therapy being delivered to the wrong anatomical location, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The ARIA Radiation Therapy Management (RTM) system is medical software used to plan and manage radiation therapy treatments. Varian has recalled versions 13.6, 15.1, 15.5, 15.6, 16.0, and 16.1 of the ARIA RTM software due to a software defect in the treatment plan and image management application.
The software issue may produce mismatch values in the treatment plan and imaging data, potentially causing radiation therapy to be delivered to an incorrect anatomical location. No illnesses or injuries have been reported in connection with this issue.
Users of the recalled software versions should immediately contact Varian Medical Systems for guidance on corrective action or updated software. Healthcare providers should implement additional verification procedures to confirm the accuracy of treatment location before administering radiation therapy to patients.
The recalled software versions have been distributed internationally, with use confirmed in Michigan, Kansas, Ohio, Virginia, Washington DC, Florida, Pennsylvania, Oklahoma, Minnesota, and Arizona in the United States, and in South Korea, the Netherlands, Poland, and China.
The recalled product
- Product
- ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
- Manufacturer
- Varian Medical Systems Imaging Laboratory GmbH
- Affected units
- 14
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 (6)
- DI Numbers: 00856100006066
- 00856100006080
- 00856100006097
- 00856100006110
- 00856100006127
- 00856100006165
Distribution
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