Class II
Medical Device Recall: 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.
PTW-FREIBURG · February 8, 2024
Reason for Recall
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.
Distribution
GA
States Affected
GA
Quantity Affected
1 US; 65 worldwide
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1181-2024
Status: ongoing
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