FDAFDA · Food and drugs·Recall number Z-1181-2024
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.
Published February 28, 2024 · Recall initiated: February 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PTW-FREIBURG
- Distributor
- GA
- Lot
- UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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