Z-1181-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- February 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 US; 65 worldwide
Product Description
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 Pattern
GA
Code Information
UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1