Varian Eclipse Treatment Planning System Software Deficiency Recall
Varian Medical Systems is recalling Eclipse Treatment Planning System software due to a defect that may cause Monitor units to change unexpectedly during dose parameter adjustments.
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 recall for a medical device used in radiation therapy. While no injuries are reported, the potential for incorrect dose delivery in a high-risk treatment context places it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Varian Medical Systems, Inc. is recalling the Plan Parameters workspace within the Eclipse Treatment Planning System Version 11 and 13, ARIA Radiation Oncology versions 11 and 13, and Acuity versions 11 and 13. The recall involves 6,701 units distributed worldwide. These software systems are used in radiation therapy simulation.
The recall is due to a software deficiency in the Plan Parameters workspace. When a dose-relevant parameter is changed and the option "do no clear MUs and Reference Point dose" is selected, the Monitor units may change unexpectedly. This anomaly could affect the accuracy of radiation therapy plans.
Healthcare providers using these systems should contact Varian Medical Systems for further instructions on how to address the software deficiency. No specific consumer action is required for the general public, as these are professional medical devices.
The recalled product
- Product
- Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 6,701
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 (2)
- Model numbers H48
- HIT
Distribution
Distribution scope not specified by the agency.
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