Varian Eclipse Treatment Planning System Recall for Dose Calculation Error
Varian Medical Systems is recalling Eclipse Treatment Planning System versions 11, 13.0, 13.5, and 13.6 due to a dose calculation error that may result in unintended radiation exposure.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states a 'Potential for unintended radiation exposure,' which aligns with the rubric criterion for Severe (4) involving significant injury reports or high-risk medical device defects.
Plain-English summary
Varian Medical Systems, Inc. is recalling the Eclipse Treatment Planning System (Eclipse TPS), Model H48, versions 11, 13.0, 13.5, and 13.6. The recall involves 9,499 units distributed worldwide, including the United States and numerous international locations.
The recall is issued because when using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments, the displayed dose does not correspond to the calculated Monitor Units (MU). This discrepancy creates a potential for unintended radiation exposure to patients.
The Eclipse TPS is used to plan radiotherapy treatments for patients with malignant or benign diseases, including external beam irradiation and brachytherapy. Healthcare facilities using these specific versions of the software should contact Varian Medical Systems for instructions on corrective actions.
The recalled product
- Product
- Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: 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…
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 9,499
Distribution
Distributed nationwide across the United States.
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