FDAFebruary 8, 2024device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
ptw freiburgptwptw freiburg
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-...2023-06-07
- FDASoftware BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S0800322021-08-27
- FDAPTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.2015-05-27
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