PTW-FREIBURG: 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.

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.

Details from the source

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 Quantity: 1 US; 65 worldwide Lot/code info: UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.