PTW-FREIBURG recalls Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medi…

Recall date

February 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1181-2024

FDA classification

Class II

Brand / firm

PTW-FREIBURG

Sold / distributed

GA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.