Class II — PTW-FREIBURG
| Recalling firm | PTW Freiburg |
|---|---|
| Registered facility | PTW FREIBURG (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 1 US; 65 worldwide |
| Distribution | GA |
| Initiated | 2024-02-08 |
| Classified | 2024-02-22 |
| Recall number | Z-1181-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PTW-FREIBURG (Z-1181-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93988/
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