Reported Feb 28, 2024 · Ongoing
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of…
Ptw-Freiburg
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PTW-FREIBURG · Lorracher Str. 7 · Freiburg Im Breisgau, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI
EPTWS070031 Software VERIQA (S070031)version 2.0 and 2.1
- UDI-DI
- Amount recalled
- 1 US; 65 worldwide
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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