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PTW-FREIBURG recalls Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medic
Recalled February 28, 2024 · FDA recall Z-1181-2024 · PTW-FREIBURG
Hazard
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. · FDA Class II
Units
1 US; 65 worldwide
Sold at
GA
Description
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.
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(s)
PTW-FREIBURG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →