Recall archive / FDA device enforcement
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of me... — FDA record Z-1181-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- PTW-FREIBURG
- Quantity
- 1 US; 65 worldwide
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1181-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
GA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 28, 2024
- Recall initiation date
- Feb 8, 2024
- Center classification date
- Feb 22, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.