Feb

2024

FDA Recall: Overestimated GPR Can Show False Positive Results

Company: PTW-FREIBURG
Date of Enforcement Report: 2/22/2024
Class II

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.

Recall Number:

Z-1181-2024

REASON:

Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.

RECALLING FIRM/MANUFACTURER:

PTW-FREIBURG

VOLUME OF PRODUCT IN COMMERCE:

1 US; 65 worldwide

DISTRIBUTION:

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Overestimated GPR Can Show False Positive Results

Allison Pate

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