Varian Eclipse Treatment Planning System Proton Algorithm Recall
Varian Medical Systems is recalling the Eclipse Treatment Planning System due to a software error in the Proton Convolution Superposition algorithm that miscalculates dose ranges for non-square CT images.
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: The recall involves a medical device software defect that results in erroneous dose calculations for radiotherapy, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Varian Medical Systems, Inc. is recalling the Eclipse(TM) Treatment Planning System (Eclipse TPS) with the Proton Convolution Superposition (PCS) algorithm license. The recall affects versions 13.X and 15.X of the software, which are used to plan radiotherapy treatments for patients with malignant or benign diseases.
The recall is due to an anomaly in the PCS dose calculation algorithm. The algorithm incorrectly calculates the water equivalent range for non-square 3D CT images, which occur when the number of pixels in the X and Y directions differs or when the pixels are not square. The software erroneously assumes uniform resolution and sets the Y dimension equal to the X dimension for dose calculation, resulting in erroneous computed water equivalent ranges.
The affected devices were distributed worldwide, including the United States and countries such as Australia, Brazil, Denmark, France, Germany, Japan, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan, and the United Kingdom. Users of the Eclipse TPS should contact Varian Medical Systems for further instructions regarding the software update or correction.
The recalled product
- Product
- Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external…
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 1,450
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 (1)
- Versions 13.X and 15.X
Distribution
Distributed nationwide across the United States.
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