Varian Eclipse Treatment Planning System Software Recall for Contouring Errors
Varian Medical Systems is recalling 42 Eclipse Treatment Planning System devices due to a software defect that prevents contours from saving consistently.
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 high-risk medical device used for radiotherapy planning where a software defect could lead to treatment errors, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported harm.
Plain-English summary
Varian Medical Systems, Inc. is recalling 42 units of the Eclipse Treatment Planning System (Eclipse TPS), version 13.MR2, equipped with Smart Segmentation Knowledge Based Contouring version 2.3. The affected devices are identified by Model # H48 and specific serial numbers listed in the recall documentation.
The recall is due to a software defect in version 13.6MR2 affecting the Contouring, SmartAdapt, and SmartSegmentation workspaces. This issue results in contours not being saved consistently within the system. The defect only occurs when certain specific conditions are fulfilled.
The affected devices were distributed in the United States to the states of New Jersey, Tennessee, Oregon, and Florida. The Eclipse TPS is used to plan radiotherapy treatments for patients with malignant or benign diseases, including external beam irradiation and brachytherapy.
The recalled product
- Product
- Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign…
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 42
Distribution
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