Radiation Oncology Treatment Planning Software VERIQA Calculation Error
PTW-FREIBURG's VERIQA software (versions 2.0 and 2.1) may incorrectly calculate gamma passing rates when users exclude voxels below a dose threshold, potentially displaying false positive dose evaluation results.
What this means for you
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 an FDA Class II device involving a software calculation error that could affect the accuracy of medical treatment plan evaluation. Although no patient deaths, hospitalizations, or injuries have been reported, this qualifies as a risk-of-harm product where the potential for incorrect dose evaluation results has not yet resulted in reported patient harm, meeting the Score 3 (High) criterion.
Plain-English summary
VERIQA is a software package used in radiation oncology for display, evaluation, and digital processing of medical image data and treatment plans. When users employ the "Suppress gamma calculation" feature to exclude voxels from the gamma calculation below a dose threshold, the software does not correctly calculate the Gamma Passing Rate for individual regions of interest. Instead, the software overestimates the correct gamma passing rate, which can result in false positive evaluation results.
This calculation error may lead to inaccurate assessment of treatment plan quality and could affect clinical decision-making regarding dose acceptability. Radiation oncology facilities using VERIQA software versions 2.0 and 2.1 should review any treatment evaluations performed while the "Suppress gamma calculation" feature was enabled to verify the accuracy of those assessments.
The recalled product
- Product
- Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
- Manufacturer
- PTW-FREIBURG
- Hazard
- calculation-error
- dose-evaluation-error
- software-bug
- false-positive-results
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)
- UDI-DI: EPTWS070031 Software VERIQA (S070031)
- version 2.0 and 2.1
Distribution
Distributed in 1 state:
- GA
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