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:
GA
