Varian Medical Systems Recalls C-Series Linear Accelerators for Software Correction
Varian Medical Systems is recalling 3,809 C-Series linear accelerators to install a software solution that corrects a previous issue.
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, which typically corresponds to a moderate severity. The source text describes a software correction for a previous issue without reporting specific injuries, deaths, or hospitalizations, fitting the criteria for a moderate risk level.
Plain-English summary
Varian Medical Systems, Inc. is recalling 3,809 C-Series high energy linear accelerators, including Clinac, Trilogy, Trilogy Tx., and Novalis models, as well as the UNIQUE single energy linear accelerator. The affected devices are running software versions 7, 8, and 9. The UNIQUE model is not sold in the United States.
The recall is a correction to notify users that a solution to a previous correction has been developed. Varian representatives will contact locations to schedule the installation of this solution. The devices are distributed worldwide, including nationwide in the USA and in numerous other countries.
Users of these devices should wait for contact from Varian representatives to schedule the installation of the software solution.
The recalled product
- Product
- C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic…
- Manufacturer
- Varian Medical Systems, Inc.
- Hazard
- Affected units
- 3,809
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 numbers Hl4
- HIS
- H27
Distribution
Distributed nationwide across the United States.
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