FDA recall Z-1181-2024

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.

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

Key facts

Status

Ongoing

Initiation date

2024-02-08

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Freiburg Im Breisgau, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1181-2024